PMA supplement
P200015 S011: Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent
FDA PMA supplement · Panel Track · Edwards Lifesciences, LLC
Key facts
| Original PMA | P200015 |
|---|---|
| Supplement number | S011 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent |
| Generic name | Pulmonary valve prosthesis percutaneously delivered |
| Applicant | Edwards Lifesciences, LLC |
| Product code | NPV |
| Received date | Jun 21, 2021 |
| Decision date | Dec 16, 2021 |
| Docket number | 21M-1325 |
| Notice date | Dec 17, 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: