PMA supplement
P010012 S387: COGNIS,ENERGEN,PUNCTUA,INCEPTA,ORIGEN,INOGEN,DYNAGEN,AUTOGEN CRT-DS
FDA PMA supplement · Real-Time Process · Boston Scientific Corp
Key facts
| Original PMA | P010012 |
|---|---|
| Supplement number | S387 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | COGNIS,ENERGEN,PUNCTUA,INCEPTA,ORIGEN,INOGEN,DYNAGEN,AUTOGEN CRT-DS |
| Generic name | Pacemaker/icd/crt non-implanted components |
| Applicant | Boston Scientific Corp |
| Product code | OSR |
| Received date | Apr 27, 2015 |
| Decision date | Jul 21, 2015 |
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: