PMA
P250019: SAPIEN M3 Transcatheter Mitral Valve Replacement System
FDA PMA · Prosthesis, mitral valve, percutaneously delivered · Edwards Lifesciences, LLC
Key facts
| PMA number | P250019 |
|---|---|
| Trade name | SAPIEN M3 Transcatheter Mitral Valve Replacement System |
| Generic name | Prosthesis, mitral valve, percutaneously delivered |
| Applicant | Edwards Lifesciences, LLC |
| Owner/operator | Edwards Lifesciences LLC |
| Product code | NPU |
| Approval date | Dec 22, 2025 |
| Docket number | FDA-7398 |
| Notice date | Dec 30, 2025 |
| Establishment registration | 2015691 |
| FEI number | 2015691 |
At a glance
- 1–9 Supplements
- Jul 29, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: