PMA supplement
P040021 S061: Epic Elite Mitral; Epic Elite Aortic; Epic Supra G3 valves
FDA PMA supplement · Normal 180 Day Track · ABBOTT MEDICAL
Key facts
| Original PMA | P040021 |
|---|---|
| Supplement number | S061 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | Epic Elite Mitral; Epic Elite Aortic; Epic Supra G3 valves |
| Generic name | Heart-valve, non-allograft tissue |
| Applicant | ABBOTT MEDICAL |
| Product code | LWR |
| Received date | Dec 22, 2025 |
| Decision date | Jun 22, 2026 |
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: