# ABBOTT MEDICAL: PMA supplement approved for Epic Elite Mitral; Epic Elite Aortic; Epic Supra G3 valves

**Score:** 30/100

| Field | Value |
|---|---|
| Sponsor | ABBOTT MEDICAL |
| Product | Epic Elite Mitral; Epic Elite Aortic; Epic Supra G3 valves |
| Generic / ingredient | heart-valve, non-allograft tissue |
| Approval | PMA supplement (device change) |
| Application | P040021 S061 |
| Decided | 2026-06-22 |
| 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=P040021S061). 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.