PMA
P240042: Tendyne Transcatheter Mitral Valve System
FDA PMA · Prosthesis, mitral valve, percutaneously delivered · ABBOTT MEDICAL
Key facts
| PMA number | P240042 |
|---|---|
| Trade name | Tendyne Transcatheter Mitral Valve System |
| Generic name | Prosthesis, mitral valve, percutaneously delivered |
| Applicant | ABBOTT MEDICAL |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | NPU |
| Approval date | May 23, 2025 |
| Docket number | 25M-1506 |
| Notice date | Jun 2, 2025 |
| Establishment registration | 3007113487 |
| FEI number | 3007113487 |
At a glance
- 1–9 Supplements
- Aug 31, 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- No Withdrawn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: