FDA device listing
Accent; Sustain XL SC, DC, SR, DR;,Allure RF, Allure Quadra RF, Allure, Allure Quadra, Endurity, Assurity+, and Assurity…
FDA device listing 1346726378 · ABBOTT LABORATORIES
Key facts
| Proprietary names | Accent; Sustain XL SC, DC, SR, DR;,Allure RF, Allure Quadra RF, Allure, Allure Quadra, Endurity, Assurity+, and Assurity Family of Pacemakers,Identity ADX, Identity, DC, VDR, Integrity ADx XL, Integrity DR, SR, Verity ADx XL, DR, XL , DC, VDR,Medical Adhesive, Integrity Micro SR DR, ECG Adapter Cable,,Merlin Patient Care System Software Model 3330 Version 18.1.1,Pacing System Analyzer Wand… |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Premarket submissions | P880086 |
| Product codes | DTB, DXY, KRG, LWP, LWS, NIK, NKE, NVZ |
| Device names | DTB - Permanent Pacemaker Electrode, DXY - Implantable Pacemaker Pulse-Generator, KRG - Programmer, Pacemaker, LWP - Implantable Pulse Generator, Pacemaker (Non-Crt), LWS - Implantable Cardioverter Defibrillator (Non-Crt), NIK - Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D), NKE - Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P), NVZ - Pulse Generator, Permanent, Implantable |
| Device class | Class III |
| Classification regulations (21 CFR) | 870.3610, 870.3680, 870.3700, ORCA1.LWP, ORCA1.LWS, ORCA1.NIK, ORCA1.NKE, ORCA1.NVZ |
| Review panels | Cardiovascular |
| Registered establishments | Abbott Medical, ABBOTT MEDICAL |
| Establishment registrations | 2017865, 3006705815, 3008494315, 3013288201 |
| FEI numbers | 2017865, 3006705815, 3008377825, 3013288201 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database