PMA supplement
P140031 S162: Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve Systems
FDA PMA supplement · Panel Track · Edwards Lifesciences, LLC
Key facts
| Original PMA | P140031 |
|---|---|
| Supplement number | S162 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve Systems |
| Generic name | Prosthesis, mitral valve, percutaneously delivered |
| Applicant | Edwards Lifesciences, LLC |
| Product code | NPU |
| Received date | Aug 1, 2023 |
| Decision date | May 23, 2024 |
| Docket number | 24M-2539 |
| Notice date | May 31, 2024 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: