PMA supplement
P010012 S341: DYNAGEN & DYNAGEN X4 CRT-D'S; INOGEN & INOGEN X4 CRT-D'S; ORIGEN & ORIGEN X4 CRT-D'S; COGNIS CRT-D
FDA PMA supplement · Normal 180 Day Track · Boston Scientific Corp
Key facts
| Original PMA | P010012 |
|---|---|
| Supplement number | S341 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | DYNAGEN & DYNAGEN X4 CRT-D'S; INOGEN & INOGEN X4 CRT-D'S; ORIGEN & ORIGEN X4 CRT-D'S; COGNIS CRT-D |
| Generic name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
| Applicant | Boston Scientific Corp |
| Product code | NIK |
| Received date | Sep 30, 2013 |
| Decision date | Apr 11, 2014 |
At a glance
- No Expedited review granted
- Yes 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: