PMA supplement
P140031 S197: Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve, Models 9755RSL20, 9755RSL23, 9755RSL26, and 9755RSL29
FDA PMA supplement · 30-Day Notice · Edwards Lifesciences, LLC
Key facts
| Original PMA | P140031 |
|---|---|
| Supplement number | S197 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve, Models 9755RSL20, 9755RSL23, 9755RSL26, and 9755RSL29 |
| Generic name | Aortic valve, prosthesis, percutaneously delivered |
| Applicant | Edwards Lifesciences, LLC |
| Product code | NPT |
| Received date | Nov 21, 2025 |
| Decision date | Dec 17, 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: