PMA supplement
P140031 S125: SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System
FDA PMA supplement · Panel Track · Edwards Lifesciences, LLC
Key facts
| Original PMA | P140031 |
|---|---|
| Supplement number | S125 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System |
| Generic name | Aortic valve, prosthesis, percutaneously delivered |
| Applicant | Edwards Lifesciences, LLC |
| Product code | NPT |
| Received date | Nov 18, 2020 |
| Decision date | May 13, 2021 |
| Docket number | 21M-0473 |
| Notice date | May 20, 2021 |
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: