PMA supplement
P010012 S310: CRT-D MODELS: INCEPTA N160, N161, N164, ENERGEN N140, N141, PUNCTUA N050
FDA PMA supplement · 30-Day Notice · Boston Scientific Corp
Key facts
| Original PMA | P010012 |
|---|---|
| Supplement number | S310 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | CRT-D MODELS: INCEPTA N160, N161, N164, ENERGEN N140, N141, PUNCTUA N050 |
| Generic name | Implantable pulse generator, pacemaker (non-CRT) |
| Applicant | Boston Scientific Corp |
| Product code | LWP |
| Received date | Oct 9, 2012 |
| Decision date | Nov 5, 2012 |
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: