PMA supplement
P250019 S003: SAPIEN M3 Transcatheter Mitral Valve Replacement System
FDA PMA supplement · 30-Day Notice · Edwards Lifesciences, LLC
Key facts
| Original PMA | P250019 |
|---|---|
| Supplement number | S003 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | SAPIEN M3 Transcatheter Mitral Valve Replacement System |
| Generic name | Prosthesis, mitral valve, percutaneously delivered |
| Applicant | Edwards Lifesciences, LLC |
| Product code | NPU |
| Received date | Mar 18, 2026 |
| Decision date | Apr 16, 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: