PMA supplement
P010012 S454: Autogen, Dynagen, Inogen, Origen NG3 CRT-Ds; Resonate, Vigilant, NG4 CRT-Ds; Acuity, Slit Suture Sleeve Accessory for A
FDA PMA supplement · Normal 180 Day Track No User Fee · Boston Scientific Corp
Key facts
| Original PMA | P010012 |
|---|---|
| Supplement number | S454 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Postapproval Study Protocol - OSB |
| Trade name | Autogen, Dynagen, Inogen, Origen NG3 CRT-Ds; Resonate, Vigilant, NG4 CRT-Ds; Acuity , Slit Suture Sleeve Accessory for A |
| Generic name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
| Applicant | Boston Scientific Corp |
| Product code | NIK |
| Received date | May 31, 2017 |
| Decision date | Jul 25, 2017 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
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 · Source date: