PMA supplement
P130009 S057: EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES
FDA PMA supplement · Panel Track · Edwards Lifesciences, LLC
Key facts
| Original PMA | P130009 |
|---|---|
| Supplement number | S057 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES |
| Generic name | Aortic valve, prosthesis, percutaneously delivered |
| Applicant | Edwards Lifesciences, LLC |
| Product code | NPT |
| Received date | May 2, 2016 |
| Decision date | Aug 18, 2016 |
| Docket number | 16M-2498 |
| Notice date | Aug 19, 2016 |
At a glance
- Yes 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: