PMA
P230013: Edwards EVOQUE Tricuspid Valve Replacement System
FDA PMA · Percutaneously Delivered Prostheses and Tricuspid Valves · Edwards Lifesciences, LLC
Key facts
| PMA number | P230013 |
|---|---|
| Trade name | Edwards EVOQUE Tricuspid Valve Replacement System |
| Generic name | Percutaneously Delivered Prostheses and Tricuspid Valves |
| Applicant | Edwards Lifesciences, LLC |
| Owner/operator | Edwards Lifesciences LLC |
| Product code | NPW |
| Approval date | Feb 1, 2024 |
| Docket number | 24M-0303 |
| Notice date | Feb 2, 2024 |
| Establishment registration | 2015691 |
| FEI number | 2015691 |
At a glance
- 10–99 Supplements
- Sep 16, 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- No Withdrawn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: