Orca1

Data catalog

PMA supplements

About 57K records

More records

Continuing the PMA supplements list, 1000 records per page, after P100023S118.

  1. P100023S120ION PACLITAXEL ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
  2. P100023S121ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
  3. P100023S122ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (OTW AND MR)
  4. P100023S123ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
  5. P100024S001HER2 CISH PHARMADX KIT
  6. P100024S002HER2 CISH PHARMDX KIT
  7. P100024S003HER2 CISH PHARMDX KIT
  8. P100024S004HER2 CISH PHARMDX KIT
  9. P100024S005HER2 CISH PHARMDX KIT
  10. P100024S006HER2 CISH PHARMDX KIT
  11. P100024S007HER2 CISH PHARMDX KIT
  12. P100024S008HER2 CISH PHARMDX KIT
  13. P100024S009HER2 CISH PHARMDX KIT
  14. P100024S010HER2 CISH PHARMDX KIT
  15. P100024S011HER2 CISH PHARMDX KIT
  16. P100024S012HER2 CISH pharmDX Kit
  17. P100024S013HER2 CISH pharmDx Kit
  18. P100025S001BREATH TEK UBTFOR H. PYLORI KIT
  19. P100025S002BREATH TEK UBT FOR H PYLORI KIT (BREATH TEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE…
  20. P100025S003BREATHTEK UBT FOR H. PYLORI HIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE…
  21. P100025S004BREATH TEK UBT FOR H. PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE…
  22. P100025S005BREATHTEK UBT FOR H.PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE…
  23. P100025S006BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION…
  24. P100025S007BREATH TEK UBT FOR H PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE…
  25. P100025S008BREATHTEK UBT FOR H.PYLORI KIT
  26. P100025S009BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION…
  27. P100025S010BREATH TEK UBT FOR H.PYLORI KIT (BREATH TEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE…
  28. P100025S011BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION…
  29. P100025S012BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION…
  30. P100025S013BreathTek UBT for H.pylori Kit (BreathTek UBT Kit), Pediatric Urea Hydrolysis Rate…
  31. P100025S014BreathTek UBT for H. pylori Kit and Pediatric Urea Hydrolysis Rate Calculation Application…
  32. P100026S001NEUROPACE RNS SYSTEM
  33. P100026S002NEUROPACE RNS SYSTEM
  34. P100026S003NEUROPACE RNS SYSTEM
  35. P100026S004NEUROPACE RNS SYSTEM
  36. P100026S005NEURO PACE RNS SYSTEM
  37. P100026S006NEUROPACE RNS SYSTEM
  38. P100026S007NEUROPACE RNS SYSTEM
  39. P100026S008NEUROPACE RNS SYSTEM
  40. P100026S009NEUROPACE RNS SYSTEM
  41. P100026S010NEUROPACE RNS SYSTEM
  42. P100026S011NEUROPACE RNS SYSTEM
  43. P100026S013NEUROPACE RNS SYSTEM
  44. P100026S014NEUROPACE RNS SYSTEM
  45. P100026S015NEUROPACE RNS SYSTEM
  46. P100026S016NEUROPACE RNS SYSTEM
  47. P100026S017NEUROPACE RNS SYSTEM
  48. P100026S018NEUROPACE RNS SYSTEM
  49. P100026S019NEUROPACE RNS SYSTEM
  50. P100026S020NEUROPACE RNS SYSTEM
  51. P100026S021NEUROPACE RNS SYSTEM
  52. P100026S022NEUROPACE RNS SYSTEM
  53. P100026S023NEUROPACE RNS SYSTEM
  54. P100026S024NEUROPACE RNS SYSTEM
  55. P100026S025NEUROPACE RNS SYSTEM
  56. P100026S026NEUROPACE RNS SYSTEM
  57. P100026S027NEUROPACE RNS SYSTEM
  58. P100026S028NEUROPACE RNS SYSTEM
  59. P100026S029NEUROPACE RNS SYSTEM
  60. P100026S030NEUROPACE RNS SYSTEM
  61. P100026S031NEUROPACE RNS SYSTEM
  62. P100026S032NEUROPACE RNS SYSTEM
  63. P100026S033NEUROPACE RNS SYSTEM
  64. P100026S034NEUROPACE RNS SYSTEM
  65. P100026S035NEUROPACE RNS SYSTEM
  66. P100026S036NEUROPACE RNS SYSTEM
  67. P100026S037NEUROPACE RNS SYSTEM
  68. P100026S038NEUROPACE RNS SYSTEM
  69. P100026S039NEUROPACE RNS SYSTEM
  70. P100026S040NEUROPACE RNS SYSTEM
  71. P100026S041NEUROPACE RNS SYSTEM
  72. P100026S042NEUROPACE RNS SYSTEM
  73. P100026S043NEUROPACE RNS SYSTEM
  74. P100026S044NEUROPACE RNS SYSTEM
  75. P100026S045NEUROPACE RNS SYSTEM
  76. P100026S046NEUROPACE RNS SYSTEM
  77. P100026S047NeuroPace RNS System
  78. P100026S048NeuroPace RNS System
  79. P100026S049NeuroPace RNS System
  80. P100026S050NeuroPace RNS System
  81. P100026S051NeuroPace RNS System
  82. P100026S052NeuroPace RNS System
  83. P100026S053NeuroPace RNS System
  84. P100026S054NeuroPace RNS System
  85. P100026S056NeuroPace RNS System
  86. P100026S057NeuroPace RNS System
  87. P100026S058NeuroPace RNS System
  88. P100026S059NeuroPace RNS System
  89. P100026S060NeuroPace RNS System
  90. P100026S061NeuroPace RNS System
  91. P100026S063NeuroPace RNS System
  92. P100026S065NeuroPace RNS System
  93. P100026S066NeuroPace RNS System
  94. P100026S067NeuroPace RNS System
  95. P100026S068NeuroPace RNS System
  96. P100026S069NeuroPace RNS System
  97. P100026S070NeuroPace RNS System
  98. P100026S071NeuroPace RNS System
  99. P100026S072NeuroPace RNS System
  100. P100026S073NeuroPace RNS System
  101. P100026S074NeuroPac RNS System
  102. P100026S075NeuroPace RNS System
  103. P100026S076NeuroPace RNS System
  104. P100026S078NeuroPace RNS System
  105. P100026S079NeuroPace RNS System
  106. P100026S080NeuroPace RNS System
  107. P100026S081NeuroPace RNS System
  108. P100026S082NeuroPace RNS System
  109. P100026S083NeuroPace RNS System
  110. P100026S084NeuroPace RNS System
  111. P100026S085Neuropace RNS System
  112. P100026S086NeuroPace RNS System
  113. P100026S087NeuroPace® RNS® System
  114. P100026S088NeuroPace® RNS® System
  115. P100026S089NeuroPace® RNS® System
  116. P100026S090NeuroPace RNS System
  117. P100026S091NeuroPace® RNS® System
  118. P100026S092NeuroPace® RNS® System
  119. P100026S093NeuroPace® RNS® System
  120. P100026S094NeuroPace® RNS® System
  121. P100026S095NeuroPace RNS System
  122. P100026S096NEUROPACE RNS SYSTEM
  123. P100026S097NeuroPace Remote Monitor
  124. P100026S098NEUROPACE RNS SYSTEM
  125. P100026S099NeuroPace® RNS® System
  126. P100026S100NeuroPace® RNS® System
  127. P100026S101NeuroPace® RNS® System
  128. P100026S103NeuroPace® RNS® System
  129. P100026S104NeuroPace® RNS® System
  130. P100027S001INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
  131. P100027S002INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
  132. P100027S003INFORM HER-2 DUAL DNA PROBE COCKTAIL
  133. P100027S004INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL
  134. P100027S005INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL
  135. P100027S006INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
  136. P100027S007INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
  137. P100027S008INFORM HER2 DUAL ISH DNA PROBE COCTAIL
  138. P100027S009INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
  139. P100027S010INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL
  140. P100027S011INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL
  141. P100027S012INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
  142. P100027S013INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
  143. P100027S014INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
  144. P100027S015INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
  145. P100027S016INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
  146. P100027S017INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
  147. P100027S018INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
  148. P100027S019INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
  149. P100027S020INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL
  150. P100027S021INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
  151. P100027S022INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL
  152. P100027S023INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
  153. P100027S024INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
  154. P100027S025INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
  155. P100027S026INFORM HER2 Dual ISH DNA Probe Cocktail
  156. P100027S027Inform HER2 Dual ISH DNA Probe Cocktail
  157. P100027S029INFORM HER2 Dual ISH DNA Probe Cocktail
  158. P100027S030INFORM HER2 Dual ISH DNA Probe Cocktail assays
  159. P100027S031Inform HER2 Dual ISH DNA Probe Cocktail
  160. P100027S032INFORM HER2 Dual ISH DNA Probe Cocktail
  161. P100027S033INFORM HER2 Dual ISH DNA Probe Cocktail
  162. P100027S034INFORM HER2 Dual ISH DNA Probe Cocktail
  163. P100027S035INFORM HER2 Dual ISH DNA Probe Cocktail
  164. P100027S036INFORM HER2 Dual ISH DNA Probe Cocktail
  165. P100027S037INFORM HER2 Dual ISH DNA Probe Cocktail
  166. P100027S038INFORM HER2 Dual ISH DNA Probe Cocktail
  167. P100027S039INFORM HER2 Dual ISH DNA Probe Cocktail
  168. P100027S040INFORM HER2 Dual ISH DNA Probe Cocktail
  169. P100027S041INFORM HER2 Dual ISH DNA Probe Cocktail
  170. P100028S001FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM
  171. P100028S002FORMULA BALLOOL-EXPANDABLE RENAL STENT SYSTEM
  172. P100028S003FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM
  173. P100028S004FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM
  174. P100029S001TRIFECTA VALVE
  175. P100029S002TRIFECTA VALVE
  176. P100029S003TRIFECTA HEART VALVE
  177. P100029S004TRIFECTA VALVE
  178. P100029S005TRIFECTA VALVE
  179. P100029S006TRIFECTA VALVE
  180. P100029S007TRIFECTA VALVE
  181. P100029S008TRIFECA HEART VALVE
  182. P100029S009TRIFECTA VALVE
  183. P100029S010TRIFECA VALVE
  184. P100029S011TRIFECTA VALVE
  185. P100029S012TRIFECTA VALVE
  186. P100029S013TRIFECTA VALVE
  187. P100029S014TRIFECTA VALVE
  188. P100029S015TRIFECTA VALVE
  189. P100029S016TRIFECTA VALVE
  190. P100029S017TRIFECTA VALVE
  191. P100029S018TRIFECTA VALVE
  192. P100029S019TRIFECTA VALVE
  193. P100029S020TRIFECTA VALVE
  194. P100029S021TRIFECTA VALVE WITH GLIDE TECHNOLOGY
  195. P100029S022BIOCOR VALVE, SUPRA VALVE; EPIC VALVE, SUPRA VALVE; TRIFECTA VALVE, TRIFECTA VALVE WITH…
  196. P100029S023ST JUDE MEDICAL TRIFECTA VALVE
  197. P100029S024TRIFECTA VALVE, VALVE WITH GLIDE
  198. P100029S025Trifecta Valve with Glide
  199. P100029S027Trifecta Valve with Glide Technology (Trifecta GT)
  200. P100029S028Trifecta Heart Valve
  201. P100029S029Trifecta Heart Valves
  202. P100029S030Trifecta and Trifecta GT
  203. P100029S031Trifecta Valve and Trifecta Valve with Glide Technology (Trifecta GT)
  204. P100029S032Trifecta Valve/Trifecta Valve with Glide Technology (Trifecta GT)
  205. P100029S033Trifecta Valve, Trifecta Valve with Glide Technology (Trifecta GT)
  206. P100029S034Trifecta Valve, Trifecta Valve with Glide Technology (Trifecta GT )
  207. P100029S035Trifecta Valve / Trifecta Valve with Glide Technology (Trifecta GT )
  208. P100029S036Trifecta Valve with Glide Technology (Trifecta GT)
  209. P100029S037Trifecta Valve with Glide Technology (Trifecta GT) Trifecta Valve.
  210. P100029S038Trifecta/Trifecta GT Valves
  211. P100029S039Trifecta and Trifecta GT surgical Heart Valve
  212. P100029S040Trifecta Valve and Trifecta Valve with Glide Technology (Trifecta GT)
  213. P100029S042Trifecta and Trifecta GT Heart Valves
  214. P100029S043Trifecta and Trifecta Valve with Glide Technology
  215. P100029S045Trifecta™ Valve with Glide Technology (Trifecta GT)
  216. P100029S046Trifecta™ and Trifecta™ Valve with Glide Technology (Trifecta™ GT) valves
  217. P100029S047Trifecta™ Valve with Glide Technology™
  218. P100029S048Trifecta™ Valve with Glide Technology™
  219. P100029S049Trifecta
  220. P100030S001ARTERX SURGICAL SEALANT 2.5ML AND 5.0 FILL VOLUMES
  221. P100030S002ARTERX SURGICAL SEALANT,
  222. P100030S004PREVELEAK SURGICAL SEALANT
  223. P100030S005PreveLeak Surgical Sealant & 10pk applictor tips
  224. P100030S007PreveLeak Surgical Sealant
  225. P100030S008PreveLeak Surgical Sealant
  226. P100030S009Water for Injection Sterile, USP
  227. P100030S010PreveLeak Surgical Sealant / PreveLeak Surgical Sealant 10pk applicator tips
  228. P100030S011PreveLeak Surgical Sealant / PreveLeak Surgical 10pk applicator tips
  229. P100030S013Preveleak Surgical Sealant
  230. P100030S014Preveleak Surgical Sealant - 1O-Pack Delivery Tips
  231. P100030S015PREVELEAK Surgical Sealant
  232. P100030S016Preveleak Surgical Sealant, Preveleak Delivery Tips - 1O pack
  233. P100030S017Preveleak Surgical Sealant
  234. P100030S018Preveleak Surgical Sealant, Preveleak I 0-pack delivery tips
  235. P100030S019Preveleak Surgical Sealant, Preveleak 10-Pack delivery Tips
  236. P100030S020Preveleak Surgical Sealant 4mL; Preveleak Delivery Tips 10 PK
  237. P100030S021Preveleak Surgical Sealant
  238. P100031S001ELECSYS ANTI-HBC IMMUNOASSAY
  239. P100031S002ELECSYS ANTI-HBC IMMUNOASSAY ON MODULAR ANALYSTICS E170
  240. P100031S003ELECSYS ANTI-HBC IMMUNOASSAY ON THE MODULAR ANALYSTICS E170 IMMUNOASSAY ANALYZER
  241. P100031S004ELECSYS ANTI-HBC IMMUNOASSAY ON MODULAR ANALYTICS E170
  242. P100031S005ELECSYS ANTI-HBC ON MODULAR ANALYTICS E170
  243. P100031S006ELECSYS ANTI-HBC ON MODULAR ANALYTICS E170
  244. P100031S008ELECSYS ANTI-HBC TEST SYSTEM
  245. P100031S009ELECSYS ANTI-HBC IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC
  246. P100031S010PRECICONTROL ANTI-HBC (MODULAR ANALYTICS E170)
  247. P100031S011ELECSYS ANTI-HBC
  248. P100031S012ELECSYS ANTI-HBC ON COBAS E 601
  249. P100031S013ELECSYS ANTI-HBC
  250. P100031S014Elecsys Anti-HBc II, PreciControl Anti-HBc
  251. P100031S015ELECSYS ANTI-HBC TEST SYSTEM
  252. P100031S016ELECSYS ANTI-HBC IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBC
  253. P100031S017Elecsys Anti-HBc Immunoassay test system
  254. P100031S018Elecsys Anti-HBc Immunoassay
  255. P100031S019Elecsys Anti-HBc
  256. P100031S020Elecsys Anti-HBc II, PreciControl Anti-HBc
  257. P100031S021Elecsys Anti-HBc II
  258. P100031S023Elecsys Anti-HBc II
  259. P100031S024Elecsys Anti-HBc II
  260. P100031S025Elecsys Anti-HBc II
  261. P100031S026Elecsys Anti-HBc II
  262. P100031S027Elecsys Anti-HBc II
  263. P100031S028Elecsys Anti-HBc II
  264. P100031S029Elecsys Anti-HBc II
  265. P100031S030Elecsys Anti-HBc II
  266. P100031S031Elecsys Anti-HBc II
  267. P100031S032Elecsys Anti-HBc II / Elecsys Anti-HBc IgM
  268. P100031S033Elecsys Anti-HBc II
  269. P100032S001ELECSYS ANTI-HBC IMMUNOASSAY
  270. P100032S002ELECSYS ANTI-HBC IMMUNOASSAY ON ELECSYS 2010
  271. P100032S003ELECSYS ANTI-HBC IMMUNOASSAY ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER
  272. P100032S004ELECSYS ANTI-HBC IMMUNOASSAY ON ELECSYS 2010
  273. P100032S005ELECSYS ANTI-HBC ON ELECSYS 2010
  274. P100032S006ELECSYS ANTI-HBC ON ELECSYS 2010
  275. P100032S007ELECSYS ANTI-HBC TEST SYSTEM
  276. P100032S008PRECICONTROL ANTI-HBC (ELECSYS) 2010
  277. P100032S009ELECSYS ANTI-HBC IMMUNOASSAY
  278. P100032S010ELECSYS ANTI-HBC
  279. P100032S011ELECSYS ANTI-HBC IMMUNOASSAY
  280. P100032S012ELECSYS ANTI-HBC TEST SYSTEM
  281. P100032S013ELECSYS ANTI-HBC IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010…
  282. P100032S014Elecsys Anti-HBC Immunoassay test system
  283. P100032S015Elecsys Anti-HBc Immunoassay
  284. P100032S016Elecsys Anti-HBc
  285. P100032S017Elecsys Anti-HBc II
  286. P100032S018Elecsys Anti-HBc II
  287. P100032S019Elecsys Anti-HBc II
  288. P100032S020Elecsys Anti-HBc II
  289. P100032S021Elecsys Anti-HBc II
  290. P100032S023Elecsys Anti-HBc II
  291. P100033S001PROGENSA PCA3 ASSAY
  292. P100033S002PROGENSA PCA3 ASSAY
  293. P100033S003PROGENSA PCA3 ASSAY
  294. P100033S004PROGENSA PCA3 ASSAY
  295. P100033S005PROGENSA PCA3 ASSAY
  296. P100033S006PROGENSA PCA3 ASSAY
  297. P100033S007Progensa PCA3 Assay
  298. P100033S008Progensa PCA3 Assay
  299. P100033S009Progensa PCA3 Assay
  300. P100033S010Progensa PCA3 Assay
  301. P100033S011Progensa PCA3 Assay
  302. P100033S012Progensa PCA3 Assay
  303. P100034S001NOVOCURE NOVOTTF-100A SYSTEM
  304. P100034S002NOVOTTF-100A SYSTEM
  305. P100034S003NOVOTTF-100A SYSTEM
  306. P100034S004NOVOTTF-100A SYSTEM
  307. P100034S005NOVA TTF-100A SYSTEM
  308. P100034S006NOVOTTF-100A SYSTEM
  309. P100034S007NOVOTFF-100A SYSTEM
  310. P100034S008NOVO TTF-100A SYSTEM
  311. P100034S009NOVOTTF-100A TREATMENT KIT
  312. P100034S010OPTUNE
  313. P100034S011NOVA TTF-100A SYSTEM
  314. P100034S012NOVOTTF-100A SYSTEM
  315. P100034S013OPTUNE (FORMERLY THE NOVOTTF-100A SYSTEM)
  316. P100034S014NOVOCURE'S OPTUNE SYSTEM
  317. P100034S015OPTUNE
  318. P100034S016NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT
  319. P100034S017Novocure Ltd.'s Optune
  320. P100034S018Optune
  321. P100034S019Optune System
  322. P100034S020Optune System
  323. P100034S021Optune System
  324. P100034S022Optune System
  325. P100034S023Optune System
  326. P100034S025Optune System
  327. P100034S026Optune System
  328. P100034S027Optune System
  329. P100034S028Optune System
  330. P100034S029Optune® device
  331. P100034S030Optune
  332. P100034S031Optune System
  333. P100034S032Optune
  334. P100034S033Optune Gio
  335. P100034S034Optune Gio
  336. P100034S035Optune System
  337. P100034S036Optune Gio
  338. P100034S037Optune Gio
  339. P100034S038Optune® Gio
  340. P100034S039Optune®
  341. P100034S040Optune®
  342. P100034S041Optune Gio™ - Maxpoint Version 2.0
  343. P100034S042Optune Gio
  344. P100034S043Optune Gio®
  345. P100034S044Optune HFE Transducer Array Soft Part Components
  346. P100034S045Novocure GmbH’s Optune Gio
  347. P100034S046Optune HFE Transducer Arrays
  348. P100039S001ADVIA CENTAUR ANTI-HBS2 ASSAY
  349. P100039S002ADVIA CENTAUR ANTI-HBS2 MASTER CURVE MATERIALS
  350. P100039S003ADVIA CENTAUR ANTI-HBS2 (AL-BS2) ASSAY
  351. P100039S004ADVIA CENTAUR ANTI HBS2 ASSAY
  352. P100039S005Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2), Atellica IM Anti-Hepatitis B…
  353. P100039S006Atellica IM Anti-Hepatitis B Surface Antigen 2 (aHBs2)
  354. P100039S007Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) Assay
  355. P100039S008ADVIA Centaur and Atellica IM Anti-HBs2 (aHBs2)
  356. P100039S009Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2)Assay
  357. P100039S010ADVIA Centaur aHBs2 Readypack Reagents and Quality Control Materials
  358. P100039S011ADVIA Centaur anti-HBs2 (aHBs2), ADVIA Centaur Anti-HBs2 (aHBs2) Quality Control Material…
  359. P100039S012ADVIA Centaur aHBs2 Assay
  360. P100039S013Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) Assay
  361. P100039S014ADVIA Centaur anti-HBs2 (aHBs2), Atellica IM aHBs2
  362. P100039S015Atellica® IM Anti-Hepatitis B surface Antigen 2 (aHBs2) Assay
  363. P100039S016Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2); Atellica IM Anti-Hepatitis B…
  364. P100039S018Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2)
  365. P100040S001VALIANT THORACIC STENT GRAFT SYSTEM
  366. P100040S002VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM
  367. P100040S003VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM
  368. P100040S004VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM
  369. P100040S005VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM
  370. P100040S006VALIANT THORACIC STENT GRAFT WITH THE CATIVIA DELIVERY SYSTEM
  371. P100040S007VALIANT THORACIC STENT GRAFT WITH THE CAPTIVA DELIVERY SYSTEM
  372. P100040S008VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM
  373. P100040S009VALIANT THORACIC STENT GRAFT
  374. P100040S010VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM
  375. P100040S011VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM
  376. P100040S012VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM
  377. P100040S013VALIANT THORACIC STENT GRAFT SYSTEM WITH CAPTIVIA DELIVERY SYSTEM
  378. P100040S014VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM
  379. P100040S015VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM
  380. P100040S016VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM
  381. P100040S017VALIANT THORACIC STENT GRAFT SYSTEM WITH CAPTIVIA DELIVERY SYSTEM
  382. P100040S019VALIANT THORACIC STENT GRAFT WITH CAPTIVA DELIVERY SYSTEM
  383. P100040S020VALIANT THORACIC STENTGRAFT WITH THE CAPTIVIA DELIVERY SYSTEM
  384. P100040S021VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM
  385. P100040S022VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM
  386. P100040S023VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM
  387. P100040S024VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM
  388. P100040S025VALIANT THORACIC STENT GRAFT WITH CAPTIVA DELIVERY SYSTEM
  389. P100040S026VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM
  390. P100040S027VALIANT THORACIC STENT GRAFT SYSTEM W/ the Captivia Delivery System
  391. P100040S028VALIANT THORACIC STENT GRAFT SYSTEM WITH CAPTIVIA DELIVERY SYSTEM
  392. P100040S029VALIANT THORACIC STENT GRAFT SYSTEM
  393. P100040S031Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant FreeFlo Tapered…
  394. P100040S032Valiant Thoracic Stent Graft System
  395. P100040S033Valiant Thoracic Stent Graft System
  396. P100040S034Valiant Thoracic Stent Graft with the Captivia Delivery System
  397. P100040S035Valiant Captivia
  398. P100040S036Valiant Navion Thoracic Stent Graft System
  399. P100040S037Valiant Thoracic Stent Graft with the Captivia Delivery System
  400. P100040S038Valiant Thoracic Stent Graft with the Captivia Delivery System
  401. P100040S039Valiant Thoracic Stent Graft With the Captivia Delivery System
  402. P100040S040Valiant Thoracic Stent Graft with Captiva Delivery System
  403. P100040S041Valiant Navion Thoracic Stent Graft System
  404. P100040S044Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant Thoracic Stent…
  405. P100040S045Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant Navion Thoracic…
  406. P100040S046Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant Navion Thoracic…
  407. P100040S047Valiant Navion Thoracic Stent Graft System, Valiant Thoracic Stent Graft with the Captivia…
  408. P100040S048Valiant Thoracic Stent Graft with the Captivia Delivery System
  409. P100040S049Valiant Thoracic Stent Graft with the Captivia Delivery System
  410. P100040S050Valiant Captivia Stent Graft ith the Captivia Delivery System
  411. P100040S051Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant Navion Thoracic…
  412. P100040S052Valiant Thoracic Stent Graft with Captivia delivery System
  413. P100040S053Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant Thoracic Stent…
  414. P100040S054Valiant Thoracic Stent Graft (FreeFlo Tapers Line Extension) with the Captivia Delivery…
  415. P100040S055Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant Thoracic Stent…
  416. P100040S056Valiant Thoracic Stent Graft with Captivia Delivery System
  417. P100040S057Valiant Thoracic Stent Graft with Captivia Delivery System, Endurant Stent Graft System…
  418. P100040S058Valiant Thoracic Stent Graft with the Captivia Delivery System
  419. P100040S059Valiant Thoracic Stent Graft with the Captivia Delivery System
  420. P100040S060Valiant Thoracic Stent Graft with the Captivia Delivery System
  421. P100040S061Valiant Thoracic Stent Graft with Captivia Delivery System
  422. P100040S062Valiant Thoracic Stent Graft with the Captivia Delivery System
  423. P100040S063Valiant Thoracic Stent Graft System (FreeFlo Tapers Line Extention) with Captivia Delivery…
  424. P100040S064Valiant Thoratic Stent Graft with Captivia Delivery System
  425. P100040S066Valiant Thoracic Stent Graft with the Captivia Delivery System
  426. P100040S067Valiant Thoracic Stent Graft with the Captivia Delivery System
  427. P100040S068Valiant Thoracic Stent Graft with the Captivia Delivery System
  428. P100040S069Valiant Thoracic Stent Graft with the Captiva Delivery System
  429. P100040S070Valiant Thoracic Stent Graft with the Captivia Delivery System
  430. P100040S071Valiant Thoracic Stent Graft with the Captivia Delivery System
  431. P100040S072Valiant Thoracic Stent Graft with the Captivia Delivery System
  432. P100040S073Valiant Thoracic Stent Graft with the Captivia Delivery System
  433. P100040S074Valiant™ Thoracic Stent Graft with the Captivia™ Delivery System
  434. P100041S001EDWARDS SAPIEN TRANSCATHETER HEART VALVE
  435. P100041S002EDWARDS SAPIEN TRANSCATHETER HEART VALVE
  436. P100041S003EDWARDS SAPIEN TRANSCATHETER HEART VALVE
  437. P100041S004EDWARDS SAPIEN TRANSCATHETER HEART VALVE
  438. P100041S005EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES
  439. P100041S006EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND RETROFLEX 3 DELIVERY SYSTEM
  440. P100041S007EDWARDS SAPIEN TRANSCATHETER HEART VALVE, MODEL 9000TFX
  441. P100041S008EDWARDS SAPIEN TRANSCATHETER HEART VALVE
  442. P100041S009EDWARDS SAPIEN TRANSCATHETER HEART VALVE (THV)
  443. P100041S010EDWARDS SAPIEN TRANSCATHETER HEART VALVE
  444. P100041S011EDWARDS SAPIEN TRANSCATHETER HEART VALVE
  445. P100041S012EDWARDS SAPIEN TRANSCATHETER HEART VALVE
  446. P100041S013EDWARDS SAPIEN THRANSCATHETER HEART VALVE (THV)
  447. P100041S014EDWARDS SAPIEN TRANSCATHETER HEART VALVE
  448. P100041S015EDWARDS SAPIEN TRANSCATHETER HEART VALVE
  449. P100041S016EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
  450. P100041S017EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES RETROFLEX 3 DELIVERY SYSTEM…
  451. P100041S018EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES, RETROFLEX 3TM DELIVERY SYSTEM…
  452. P100041S019EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
  453. P100041S020EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
  454. P100041S021SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES
  455. P100041S022EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
  456. P100041S023EDWARDS SAPIEN TRANSCATHETER HEART VALVE
  457. P100041S024EDWARDS SAPIEN TRANSCATHETER HEART VALVE
  458. P100041S027RETROFLEX 3 DELIVERY SYSTEM, RETROFLEX BALLON CATHETER, EDWARDS TRANSFEMORAL BALLON…
  459. P100041S028EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES RETROFLEX 3 DELIVERY SYSTEM
  460. P100041S029EDWARDS SAPIEN TRANSCATHETER HEART VALVE, MODEL 9000TFX
  461. P100041S030EDWARDS SAPIEN TRANSCATHETER HEART VALVE
  462. P100041S031EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES
  463. P100041S032EDWARDS SAPIEN TRANSCATHETER HEART VALVE
  464. P100041S033TRANSCATHER HEART VALVE AND TRANSFEMORAL ACCESSORIES
  465. P100041S034EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES
  466. P100041S035EDWARDS SAPIEN TRANSCATHETER HEART, MODEL 9000TFX
  467. P100041S036EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES
  468. P100041S037EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES
  469. P100041S038EDWARDS SAPIEN TRANSCATHETER HEART VALVE
  470. P100041S039EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES
  471. P100041S040EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES-RETROFLEX 3 DELIVERY SYSTEM…
  472. P100041S041EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES
  473. P100041S042EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
  474. P100041S043EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES
  475. P100041S044EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES
  476. P100041S046EDWARDS SAPIEN TRANSCATHETER HEART VALVE
  477. P100041S047EDWARDS SAPIEN TRANSCATHETER HEART VALVE
  478. P100041S048EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
  479. P100041S049EDWARDS SAPIEN TRANSCATHETER HEART VALVE
  480. P100041S050EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
  481. P100041S051EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
  482. P100041S052EDWARDS SAPIEN TRANSCATHETER HEART VALVE
  483. P100041S053EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
  484. P100041S054EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
  485. P100041S055EDWARDS SAPIEN TRANSCATHER HEART VALVE
  486. P100041S056SAPIEN THV WITH RETROFLEX FOR INOPERABLE PATIENTS AND WITH RETROFLEX OR ASCENDRA FOR HIGH…
  487. P100041S058EDWARDS SAPIEN TRANSCATHETER HEART VALVE
  488. P100041S059SAPIEN TRANSCATHETER HEART VALVE (THV)
  489. P100041S060EDWARDS SAPIEN TRANSCATHETER HEART VALVE
  490. P100041S061EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
  491. P100041S062EDWARDS SAPIEN TRANSCATHETER HEART VALVE
  492. P100041S063EDWARDS SAPIEN TRANSCATHETER HEART VALVE
  493. P100041S064EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
  494. P100041S065EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
  495. P100041S066EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
  496. P100041S068EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
  497. P100041S069EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
  498. P100042S001APTIMA HPV ASSAY
  499. P100042S002APTIMA HPV ASSAY
  500. P100042S003APTIMA HPV ASSAY
  501. P100042S004APTIMA HPV ASSAY
  502. P100042S005APTIMA HPV ASSAY
  503. P100042S007APTIMA HPV ASSAY
  504. P100042S008APTIMA HPV ASSAY
  505. P100042S009APTIMA HPV ASSAY
  506. P100042S010APTIMA HPV ASSAY
  507. P100042S011APTIMA HPV ASSAY
  508. P100042S012Aptima HPV Assay
  509. P100042S013Aptima HPV Assay
  510. P100042S014Aptima HPV Assay
  511. P100042S015Aptima HPV Assay
  512. P100042S016Aptima HPV Assay
  513. P100042S017Aptima HPV Assay
  514. P100042S018Aptima HPV Assay
  515. P100042S019Aptima HPV Assay
  516. P100042S020Aptima HPV Assay
  517. P100042S021Aptima HPV Assay
  518. P100042S022APTIMA HPV Assay
  519. P100042S023APTIMA HPV ASSAY
  520. P100042S024Aptima HPV Assay
  521. P100042S025Aptima HPV Assay
  522. P100042S026Aptima HPV Assay
  523. P100042S027Aptima HPV Assay
  524. P100042S028Aptima HPV Assay
  525. P100042S029Aptima HPV Assay
  526. P100042S030Aptima HPV Assay
  527. P100042S031Aptima HPV Assay
  528. P100042S032Aptima HPV Assay
  529. P100042S033Aptima HPV Assay
  530. P100042S034Aptima HPV Assay
  531. P100042S035Aptima HPV Assay
  532. P100042S036Aptima HPV Assay
  533. P100042S037Aptima HPV Assay
  534. P100042S038APTIMA HPV ASSAY
  535. P100042S039Aptima HPV Assay 250T (Panther) Box 1; Aptima HPV Assay 250T (Panther) Box 2; Aptima HPV…
  536. P100044S001PROPEL MINI SINUS IMPLANT
  537. P100044S002PROPEL SINUS IMPLANT
  538. P100044S003PROPEL MINI SINUS IMPLANT, 6011
  539. P100044S004PROPEL SINUS IMPLANT
  540. P100044S005PROPEL MINI SINUS IMPLANT
  541. P100044S006PROPEL MINI SINUS IMPLANTS
  542. P100044S007PROPEL AND PROPEL MINI SINUS IMPLANT
  543. P100044S008INTERSECTENT PROPEL MINI SINUS IMPLANT
  544. P100044S010PROPEL SINUS IMPLANT, PROPEL MINI SINUS IMPLANT
  545. P100044S011PROPEL SINUS IMPLANT, PROPEL MINI SINUS IMPLANT
  546. P100044S012INTERSECT ENT PROPEL MINI SINUS IMPLANT
  547. P100044S013PROPEL MINI SINUS IMPLANT
  548. P100044S014PROPEL AND PROPEL MINI SINUS IMPLANTS
  549. P100044S015PROPEL AND PROPEL MINI SINUS IMPLANTS
  550. P100044S016PROPEL SINUS IMPLANT AND PROPEL MINI SINUS IMPLANT
  551. P100044S017PROPEL SINUS IMPLANT, PROPEL MINI SINUS IMPLANT
  552. P100044S018PROPEL MINI SINUS IMPLANT
  553. P100044S019PROPEL AND PROPEL MINI SINUS IMPLANTS
  554. P100044S020PROPEL
  555. P100044S021PROPEL AND PROPEL MINI SINUS IMPLANTS
  556. P100044S022PROPEL AND PROPEL MINI SINUS IMPLANT
  557. P100044S023PROPEL CONTOUR SINUS IMPLANT
  558. P100044S024PROPEL, PROPEL MINI SINUS IMPLANT
  559. P100044S025PROPEL SINUS, MINI SINUS IMPLANT.
  560. P100044S026PROPEL SINUS IMPLANT & PROPEL MINI SINUS IMPLANT
  561. P100044S027Propel Sinus Implant & Propel mini Sinus Implant
  562. P100044S028Intersect ENT Propel Contour Sinus Implant Component Verification System Generation II
  563. P100044S029PROPEL Contour Sinus Implant Delivery System
  564. P100044S030Mometasone Furoate Container Closure System
  565. P100044S031PROPEL Contour SInus Implant
  566. P100044S032Propel, Propel mini and Propel Contour Sinus Implants
  567. P100044S033Propel Contour Sinus Implant
  568. P100044S034Propel and Propel Mini Sinus Implants
  569. P100044S035Propel Sinus Implant, Propel Mini Sinus Implant, Propel Contour Sinus Implant
  570. P100044S036Propel Family of Sinus Implants
  571. P100044S037Propel Contour Sinus Implant
  572. P100044S038Propel Mini Sinus Implant
  573. P100044S039Propel, Propel Mini and Propel Contour Sinus Implants
  574. P100044S040Propel Contour Sinus Implant
  575. P100044S041Propel Contour Sinus Implant
  576. P100044S042Propel, Propel Mini and Propel Contour Sinus Implants
  577. P100044S043Propel
  578. P100044S044Propel, Propel Mini and Propel Contour (Propel Familly) Sinus Implants
  579. P100044S045Propel Family of Sinus Implants
  580. P100044S046Propel Mini Sinus Implant
  581. P100044S048Propel and Propel Mini Sinus Implants
  582. P100044S049Propel Contour Sinus Implant
  583. P100044S050Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight…
  584. P100044S051Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight…
  585. P100044S052Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight…
  586. P100044S053Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight…
  587. P100044S054Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight…
  588. P100044S055Propel® Contour Sinus Implant
  589. P100044S056Propel®, Propel® Mini, Propel® Contour Sinus Implants
  590. P100044S057PROPEL, PROPEL MINI and PROPEL CONTOUR
  591. P100044S058Propel Contour Sinus Implant
  592. P100044S059Propel, Propel Mini (including Propel Mini with Straight Delivery System), and Propel…
  593. P100044S060Propel Family Products
  594. P100044S061PROPEL
  595. P100045S001CARDIOMEMS HF SYSTEM
  596. P100045S002CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM
  597. P100045S004CARDIOMEMS HF SYSTEM
  598. P100045S005CARDIOMEMS HF SYSTEM
  599. P100045S006CARDIOMEMS
  600. P100045S007CARDIOMEMS HF SYSTEM
  601. P100045S008CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM
  602. P100045S009CARDIOMEMS HF SYSTEM
  603. P100045S010CARDIOMEMS HF SYSTEM
  604. P100045S011CARDIOMEMS HF SYSTEM
  605. P100045S012CARDIOMEMS HF SYSTEM
  606. P100045S013CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM
  607. P100045S014CARDIOMEMS HF SYSTEM
  608. P100045S015CARDIOMEMS HF SYSTEM
  609. P100045S016CARDIOMEMS HF SYSTEM
  610. P100045S017CardioMEMS HF System
  611. P100045S018CARDIOMEMS HF SYSTEM
  612. P100045S019CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM
  613. P100045S020CardioMEMS PA Sensor and Delivery Catheter
  614. P100045S022CardioMEMS patient and hospital electronics
  615. P100045S023CardioMEMS HF System
  616. P100045S024Cardiomems HF Pressure Measurement System
  617. P100045S025CardioMems HF System
  618. P100045S026CardioMEMS HF System
  619. P100045S028CardioMEMS HF System
  620. P100045S029CardioMEMS HF System
  621. P100045S030CardioMEMS HF System
  622. P100045S031CardioMEMS HF System
  623. P100045S032CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM
  624. P100045S033CardioMEMS HF System
  625. P100045S034CardioMEMS HF (Heart Failure) System
  626. P100045S035CardioMEMS HF System
  627. P100045S036CardioMEMS HF System
  628. P100045S037CardioMEMS HF System
  629. P100045S038CardioMEMS HF System
  630. P100045S039CardioMEMS HF System
  631. P100045S040CardioMEMS HF System
  632. P100045S041CardioMEMS HF System
  633. P100045S042CardioMEMS HF System
  634. P100045S043CardioMEMS HF System
  635. P100045S044CardioMEMS HF System
  636. P100045S045CardioMEMS HS System
  637. P100045S046CardioMEMS HF System
  638. P100045S047CardioMEMS HF System
  639. P100045S048CardioMEMS HF System
  640. P100045S049CardioMEMS HF System
  641. P100045S050Cardiomems HF System
  642. P100045S051CardioMEMS I3 Patient Electronics System (PES)
  643. P100045S052CardioMEMS HF System
  644. P100045S053CardioMEMS HF System
  645. P100045S054CardioMEMS HF System
  646. P100045S055CardioMEMS HF System
  647. P100045S056CardioMEMs HF System
  648. P100045S057CardioMEMS HF System
  649. P100045S058CardioMEMS HF System
  650. P100045S059CardioMEMS™ HF System
  651. P100045S060CardioMEMS HF System
  652. P100045S061CardioMEMS HF System
  653. P100045S062CardioMEMS PA Sensor and Delivery System
  654. P100045S063CardioMEMS™ HF System
  655. P100045S064CardioMEMS HF System
  656. P100045S065CardioMEMS HF System
  657. P100045S066CardioMEMS Hospital System
  658. P100045S067CardioMEMSTM HF System
  659. P100045S068CardioMEMS HF System
  660. P100045S069CardioMEMS HF System
  661. P100045S070CardioMEMSTM HF System
  662. P100045S071CardioMEMS HF System
  663. P100045S072CardioMEMS™ HF System
  664. P100045S073CardioMEMS™ HF System
  665. P100045S074CardioMEMS Hospital System, model CM3100
  666. P100045S075CardioMEMS™ HF System
  667. P100045S076CardioMEMS HF System
  668. P100045S077CardioMEMS HF System
  669. P100045S078CardioMEMS HF System
  670. P100045S079CardioMEMS HF System
  671. P100045S080CardioMEMS HF System
  672. P100045S081CardioMEMS HF System
  673. P100045S082CardioMEMS™ HF System
  674. P100045S083CardioMEMS HF System
  675. P100045S084CardioMEMSTM HF System
  676. P100045S085CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM
  677. P100045S086Next Gen Patient System – CM1200 CardioMEMS HERO Device
  678. P100045S087CardioMEMS™ HF System (Merlin.net PCN HF Portal (Model MN6000) and CardioMEMS Backend Web…
  679. P100045S088CardioMEMS™ HF System
  680. P100045S089CardioMEMS™ HF System
  681. P100045S090CardioMEMS HF System
  682. P100045S091CardioMEMS HF System; Merlin.net PCN HF Portal (Model MN6000); CardioMEMS Backend Web…
  683. P100045S092CardioMEMS PA Sensor and Delivery System (CM2000); CardioMEMS™ HF System
  684. P100045S093CardioMEMS PA Sensor and Delivery System
  685. P100046S001ATRICURE SYNERGY ABLATION SYSTEM
  686. P100046S002ATRICURE SYNERGY ABLATION SYSTEM-OLL2, OSL2, ASU, ASB
  687. P100046S003ATRICURE SYNERGY ABLATION SYSTEM
  688. P100046S004ATRICURE SYNERGY ABLATION SYSTEM
  689. P100046S005ATRICURE SYNERGY ABLATION SYSTEM
  690. P100046S006ATRICURE SYNERGY ABLATION SYSTEM
  691. P100046S007ATRICURE SYNERGY ABLATION SYSTEM
  692. P100046S008ATRICURE SYNERGY ABLATION SYSTEM
  693. P100046S009Synergy Ablation System
  694. P100046S010AtriCure Synergy Ablation System
  695. P100046S011AtriCure Synergy Ablation System
  696. P100046S012Synergy Ablation System
  697. P100046S013AtriCure Synergy Ablation System
  698. P100046S015AtriCure Isolator Clamp, AtriCure Long Clamp, AtriCure Synergy Clamp
  699. P100046S016Multifunctional Ablation Generator (MAG)
  700. P100046S017Synergy Ablation System
  701. P100046S018Synergy Ablation System
  702. P100046S019Synergy Ablation System
  703. P100046S020Synergy Ablation System
  704. P100046S021Synergy Ablation System
  705. P100047S001HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
  706. P100047S002HEARTWARE VENTRICULAR ASSIST SYSTEM
  707. P100047S003HEARTWARE VENTRICULAR ASSIST SYSTEM
  708. P100047S004HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
  709. P100047S005HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
  710. P100047S006HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
  711. P100047S007HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
  712. P100047S008HEARTWARE VENTRICULAR ASSIST SYSTEM
  713. P100047S009HEARTWARE VENTRICULAR ASSISTE SYSTEM
  714. P100047S010HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
  715. P100047S011HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
  716. P100047S012HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
  717. P100047S013HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
  718. P100047S014HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
  719. P100047S015HEARTWARE VENTRICULAR ASSIST SYSTEM
  720. P100047S017HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
  721. P100047S018HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
  722. P100047S019HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
  723. P100047S020HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
  724. P100047S021HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
  725. P100047S022HEART WARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
  726. P100047S023HEART WARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
  727. P100047S024HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
  728. P100047S025HEARTWARE VENTRICULAR ASSIST SYSTEM
  729. P100047S026HEARTWARE VENTRICULAR ASSIST SYSTEM
  730. P100047S027HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
  731. P100047S028HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
  732. P100047S029HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
  733. P100047S030HEARTWARE VENTRICULAR ASSIST SYSTEM
  734. P100047S031HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
  735. P100047S032HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
  736. P100047S033HEART WARE VENTRICULAR ASSIST SYSTEM
  737. P100047S034HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
  738. P100047S035HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
  739. P100047S036HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
  740. P100047S037HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
  741. P100047S038HVAD SEWING RING-HEARTWARE VENTRICULAR ASSIST SYTEM
  742. P100047S039HEARTWARE VENTRICULAR ASSIST SYSTEM
  743. P100047S040HEARTWARE VENTRICULAR ASSIST SYSTEM
  744. P100047S041HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
  745. P100047S042HEARTWARE VENTRICULAR ASSIST SYSTEM
  746. P100047S043HEARTWARE VENTRICULAR ASSIST SYSTEM
  747. P100047S044HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
  748. P100047S045HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
  749. P100047S046HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
  750. P100047S047HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
  751. P100047S048HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
  752. P100047S049HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
  753. P100047S050HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
  754. P100047S051HEARTWARE VENTRICULAR ASSIST SYSTEM
  755. P100047S052HEARTWARE VENTRICULAR ASSIST SYSTEM
  756. P100047S053HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
  757. P100047S054HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
  758. P100047S055HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
  759. P100047S056HEARTWARE VENTRICULAR ASSIST SYSTEM
  760. P100047S057HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
  761. P100047S060HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
  762. P100047S061HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
  763. P100047S062HEARTWARE VENTRICULAR ASSIST SYSTEM
  764. P100047S063HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
  765. P100047S064HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
  766. P100047S065HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
  767. P100047S066HEARTWARE VENTRICULAR ASSIST SYSTEM
  768. P100047S067HEARTWARE VENTRICULAR ASSIST SYSTEM
  769. P100047S068HEARTWARE VENTRICULAR ASSIST SYSTEM
  770. P100047S069HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
  771. P100047S070HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
  772. P100047S071HEARTWARE VENTRICULAR ASSIST SYSTEM
  773. P100047S072HEARTWARE VENTRICULAR ASSIST SYSTEM
  774. P100047S073HEARTWARE VENTRICULAR ASSIST SYSTEM
  775. P100047S074HEARTWARE VENTRICULAR ASSIST SYSTEM
  776. P100047S075HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
  777. P100047S076HEARTWARE VENTRICULAR ASSIST SYSTEM
  778. P100047S077HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
  779. P100047S078HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
  780. P100047S079HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
  781. P100047S080HEARTWARE VENTRICULAR ASSIST DEVICE SYSTEM
  782. P100047S081HEARTWARE VENTRICULAR ASSIST SYSTEM
  783. P100047S082HeartWare Left Ventricular Assist System
  784. P100047S083HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
  785. P100047S084HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
  786. P100047S085HEARTWARE VENTRICULAR ASSIST DEVICE SYSTEM
  787. P100047S086HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
  788. P100047S087HEARTWARE VENTRICULAR ASSIST SYSTEM
  789. P100047S088HEARTWARE VENTRICULAR ASSIST SYSTEM
  790. P100047S089HEARTWARE VENTRICULAR ASSIST SYSTEM
  791. P100047S090HeartWare™ HVAD™ System
  792. P100047S091HeartWare Ventricular Assist System
  793. P100047S092HeartWare Ventricular Assist System
  794. P100047S093HeartWare Ventricular Assist System
  795. P100047S094HeartWare Ventricular Assist System
  796. P100047S095HeartWare Ventricular Assist System
  797. P100047S096HeartWare Left Ventricular Assist System
  798. P100047S097HeartWare Ventricular Assist Device System
  799. P100047S098HeartWare Ventricular Assist System
  800. P100047S099HeartWare Ventricular Assist System
  801. P100047S100HeartWare Ventricular Assist Device System
  802. P100047S101HeartWare HVAD System
  803. P100047S102HeartWare Ventricular Assist Device System
  804. P100047S103HeartWare Left Ventricular Assist Device System
  805. P100047S104HeartWare Ventricular Assist System
  806. P100047S105HeartWare Ventricular Assist System
  807. P100047S106HeartWare Ventricular Assist System
  808. P100047S107HeartWare Left Ventricular Assist System
  809. P100047S108HeartWare Ventricular Assist System
  810. P100047S109HeartWare Ventricular Assist System
  811. P100047S110HeartWare HVAD System
  812. P100047S111HeartWare Ventricular Assist System
  813. P100047S112HeartWare HVAD System
  814. P100047S113HeartWare Ventricular Assist System
  815. P100047S114HeartWare HVAD System
  816. P100047S115HeartWare HVAD System
  817. P100047S116HeartWare Ventricular Assist System
  818. P100047S117HeartWare Left Ventricular Assist System
  819. P100047S118HeartWare Ventricular Assist System
  820. P100047S119HeartWare Ventricular Assist System
  821. P100047S120HeartWare Left Ventricular Assist System
  822. P100047S121HeartWare Ventricular Assist System
  823. P100047S122HeartWare Left Ventricular Assist System
  824. P100047S123HeartWare Ventricular Assist System
  825. P100047S124HeartWare HVAD System
  826. P100047S125Heartware Ventricular Assist System
  827. P100047S126HeartWare Ventricular Assist System
  828. P100047S127HeartWare Ventricular Assist System
  829. P100047S129HeartWare Left Ventricular Assist System
  830. P100047S130HeartWare Ventricular Assist System
  831. P100047S131HeartWare HVAD System
  832. P100047S132HeartWare HVAD System
  833. P100047S133HeartWare Ventricular Assist System
  834. P100047S134HeartWare HVAD System
  835. P100047S135HeartWare Ventricular Assist System (HVAD)
  836. P100047S136HeartWare Ventricular Assist System
  837. P100047S137HeartWare Left Ventricular Assist Device System
  838. P100047S138HeartWare HVAD System
  839. P100047S139HeartWare HVAD System
  840. P100047S140HeartWare Left Ventricular Assist Device System
  841. P100047S141HeartWare Ventricular Assist System
  842. P100047S142HeartWare HVAD System
  843. P100047S143HeartWare Ventricular Assist System
  844. P100047S144HeartWare HVAD System
  845. P100047S145HeartWare Left Ventricular Assist Device System
  846. P100047S147HeartWare Ventricular Assist System
  847. P100047S148HeartWare HVAD System
  848. P100047S149HeartWare HVAD System
  849. P100047S150HeartWare HVAD System
  850. P100047S151HeartWare HVAD System
  851. P100047S152HeartWare Ventricular Assist System
  852. P100047S153HeartWare Ventricular Assist System
  853. P100047S154HeartWare Ventricular Assist System
  854. P100047S155HeartWare Ventricular Assist System
  855. P100047S156HeartWare Ventricular Assist System
  856. P100047S157HeartWare Ventricular Assist System
  857. P100047S158HeartWare Ventricular Assist System
  858. P100047S159HeartWare Ventricular Assist System
  859. P100047S161HeartWare Ventricular Assist System
  860. P100047S162HeartWare Ventricular Assist System
  861. P100047S163HeartWare Left Ventricular Assist System
  862. P100047S164HeartWare Ventricular Assist System
  863. P100047S166HeartWare HVAD System
  864. P100047S167HeartWare Ventricular Assist System
  865. P100047S168HeartWare Ventricular Assist System
  866. P100047S169HeartWare HVAD System
  867. P100047S170HeartWare Ventricular Assist System
  868. P100047S171HeartWare Ventricular Assist System
  869. P100047S172HeartWare Ventricular Assist System
  870. P100047S173HeartWare Ventricular Assist System
  871. P100047S174HeartWare HVAD System
  872. P100047S175HeartWare HVAD System
  873. P100047S176HeartWare HVAD System
  874. P100047S177HeartWare Left Ventricular Assist System
  875. P100047S178HeartWare Ventricular Assist System
  876. P100047S179HeartWare Ventricular Assist System
  877. P100047S180HeartWare HVAD System
  878. P100047S181HeartWare Ventricular Assist System
  879. P100047S182HeartWare Ventricular Assist System
  880. P100047S183HeartWare Ventricular Assist System
  881. P100047S184HeartWare Ventricular Assist System
  882. P100047S185HeartWare Ventricular Assist System
  883. P100047S186HeartWare Ventricular Assist System
  884. P100047S188HeartWare HVAD System
  885. P100047S189HeartWare HVAD System
  886. P100047S190HeartWare® Ventricular Assist System
  887. P100047S191HeartWare® Ventricular Assist System or HeartWare® System
  888. P100047S192HeartWare Ventricular Assist System
  889. P100047S193HeartWare® HVAD System
  890. P100047S194Heartware Ventricular Assist System
  891. P100047S195HeartWare Ventricular Assist (HVAD) System
  892. P100047S196HeartWare HVAD System
  893. P100047S197HeartWare® Ventricular Assist System
  894. P100047S198HeartWare Ventricular Assist System
  895. P100047S199HeartWare Ventricular Assist System
  896. P100047S200HeartWare HVAD System
  897. P100047S201HeartWare Ventricular Assist System
  898. P100047S202HeartWare® Ventricular Assist System
  899. P100047S204HeartWare Ventricular Assist System
  900. P100047S205HeartWare® Ventricular Assist System, HeartWare® System
  901. P100047S206HeartWare™ Ventricular Assist System
  902. P100047S207HeartWare HVAD System
  903. P100047S208Pioneer 2.0 HVAD Controller
  904. P100047S209HeartWare® Ventricular Assist System
  905. P100047S210HeartWare® Ventricular Assist System, HeartWare® System
  906. P100047S211HeartWare™ Ventricular Assist System or HeartWare™ System
  907. P100047S212HeartWare® Ventricular Assist System
  908. P100047S214HeartWare HVAD System
  909. P100047S215HeartWare™ HVAD System
  910. P100047S216HeartWare® HVAD System
  911. P100047S217HeartWare HVAD System
  912. P100047S218Heart Ware HVAD System
  913. P100047S219HEARTWARE VENTRICULAR ASSIST SYSTEM
  914. P100047S220HeartWare® HVAD System
  915. P100047S221HEARTWARE VENTRICULAR ASSIST SYSTEM
  916. P100047S222HEARTWARE VENTRICULAR ASSIST SYSTEM
  917. P100047S223HEARTWARE VENTRICULAR ASSIST SYSTEM
  918. P100047S224HeartWare HVAD System
  919. P100047S225HeartWare® HVAD System
  920. P100047S226HeartWare HVAD System
  921. P100047S227HeartWare HVAD System
  922. P100047S228HEARTWARE VENTRICULAR ASSIST SYSTEM
  923. P100047S229HeartWare™ Ventricular Assist System (HVAD)
  924. P100047S230HeartWare­™ Ventricular Assist System (HVAD)
  925. P100047S234HeartWare® HVAD System
  926. P100047S235HeartWare HVAD System
  927. P100047S236HeartWare® HVAD System
  928. P100047S238Heart Ware™ Ventricular Assist System (HVAD)
  929. P100047S239HeartWare® Ventricular Assist System
  930. P100047S240HeartWare™ HVAD™ System
  931. P100047S241HeartWare® HVAD System
  932. P100049S001LINX REFLUX MANAGEMENT SYSTEM
  933. P100049S002LINX REFLUX MANAGEMENT SYSTEM
  934. P100049S003LINX REFLUX MANAGEMENT SYSTEM
  935. P100049S004LINX REFLUX MANAGEMENT SYSTEM
  936. P100049S005LINX REFLUX MANAGEMENT SYSTEM
  937. P100049S006LINX REFLUX MANAGEMENT SYSTEM
  938. P100049S007LINX REFLUX MANAGEMENT SYSTEM
  939. P100049S008LINX REGLUX MANAGEMENT SYSTEM
  940. P100049S009LINX REFLUX MANAGEMENT SYSTEM
  941. P100049S010LINX REFLUX MANAGEMENT SYSTEM
  942. P100049S011LINX REFLUX MANAGEMENT SYSTEM
  943. P100049S012LINX REFLUX MANAGEMENT SYSTEM
  944. P100049S013LINX REFLUX MANAGEMENT SYSTEM
  945. P100049S014LINX REFLUX MANAGEMENT SYSTEM
  946. P100049S015LINX REFLUX MANAGEMENT SYSTEM
  947. P100049S016LINX REFLUX MANAGEMENT SYSTEM
  948. P100049S017LINX REFLUX MANAGEMENT SYSTEM
  949. P100049S018LINX REFLUX MANAGEMENT SYSTEM, IMPLANT AND SIZING TOOL
  950. P100049S019LINX REFLUX MANAGEMENT SYSTEM
  951. P100049S020Linx Reflux Management System
  952. P100049S021Linx Reflux Management System
  953. P100049S022LINX Reflux Management System
  954. P100049S023LINX Reflux Management System
  955. P100049S024LINX Reflux Management System
  956. P100049S025LINX Reflux Management System
  957. P100049S026LINX Reflux Mnagement System
  958. P100049S027LINX Reflux Management System
  959. P100049S028Linx Reflux Management System
  960. P100049S029LINX Reflux Management System
  961. P100049S030LINX Reflux Management System
  962. P100049S031LINX Reflux Management System
  963. P100049S032LINX Reflux Management System
  964. P100049S033LINX Reflux Management System
  965. P100049S034LINX Reflux Management System
  966. P100049S035LINX Reflux Management System
  967. P100049S036LINX Reflux Management System
  968. P100049S037LINX Reflux Management System
  969. P100049S038LINX Reflux Management System
  970. P100049S040LINX™ Reflux Management System
  971. P100049S041LINX Reflux Management System
  972. P110001S001RX HERCULINK ELITE RENAL AND BILIARY STENT SYSTEM
  973. P110001S002ADAPTER 2D MATRIX BARCODE VERIFICATION SYSTEM
  974. P110001S003RX HECULINK ELITE RENAL STENT SYSTEM
  975. P110001S004HERCULINK ELITE RENAL STENT SYSTEM
  976. P110001S005HERCULINK ELITE, RX
  977. P110001S006HERCULINK ELITE PERIPHERAL STENT SYSTEM
  978. P110001S007RX HERCULINK ELITE RENAL STENT SYSTEM
  979. P110001S008HERCULINK ELITE RX STENT SYSTEM
  980. P110001S009RX HERCULINK ELITE RENAL STENT SYSTEM
  981. P110001S010RX HERCULINK ELITE RENAL STENT SYSTEM
  982. P110001S011RX HERCULINK ELITE RENAL STENT SYSTEM
  983. P110001S012RX HERCULINK ELITE RENAL STENT SYSTEM
  984. P110001S013Rx Herculink Elite Renal and Biliary Stent System
  985. P110001S014RX Herculink Elite Renal and Biliary Stent System
  986. P110001S015RX Herculink Elite Renal and Biliary Stent System
  987. P110001S016RX Herculink Elite Renal and Biliary Stent System
  988. P110001S017RX Herculink Elite Renal Stent System
  989. P110001S018RX Herculink Elite Renal Stent System
  990. P110001S020RX Herculink Elite Renal and Biliary Stent System
  991. P110001S021RX HERCULINK ELITE RENAL STENT SYSTEM
  992. P110001S022RX Herculink Elite
  993. P110002S001MOBI-C CERVICAL DISC PROSTHESIS
  994. P110002S002MOBI-C CERVICAL DISC PROSTHESIS
  995. P110002S003MOBI-C CERVICAL DISC PROSTHESIS
  996. P110002S004MOBI-C CERVICAL DISC PROSTHESIS FOR USE AT ONE OR TWO LEVELS
  997. P110002S005MOBI-C CERVICAL DISC PROSTHESIS (ONE LEVEL)
  998. P110002S006MOBI-C CERVICAL DISC PROSTHESIS
  999. P110002S007LDR SPINE MOBI-C CERVICAL DISC PROTHESIS (ONE LEVEL INDICATION)
  1000. P110002S008MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION)

About this dataset

A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.

Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database