# Boston Scientific Corp: PMA supplement approved for COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, V

**Score:** 30/100

| Field | Value |
|---|---|
| Sponsor | Boston Scientific Corp |
| Product | COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILIANT |
| Generic / ingredient | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
| Approval | PMA supplement (device change) |
| Application | P010012 S607 |
| Decided | 2026-07-01 |
| Panel / class | Cardiovascular |
| Sponsor location | St Paul, MN |

## Why this score


Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010012S607). Last refreshed: 2026-11-04T06:06:18.796Z.
From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.