PMA supplement
P230013 S019: EVOQUE Tricuspid Valve Replacement System
FDA PMA supplement · Real-Time Process · Edwards Lifesciences, LLC
Key facts
| Original PMA | P230013 |
|---|---|
| Supplement number | S019 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | EVOQUE Tricuspid Valve Replacement System |
| Generic name | Percutaneously Delivered Prostheses and Tricuspid Valves |
| Applicant | Edwards Lifesciences, LLC |
| Product code | NPW |
| Received date | Aug 21, 2025 |
| Decision date | Nov 19, 2025 |
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: