PMA supplement
P100041 S056: SAPIEN THV WITH RETROFLEX FOR INOPERABLE PATIENTS AND WITH RETROFLEX OR ASCENDRA FOR HIGH RISK OPERABLE
FDA PMA supplement · Normal 180 Day Track No User Fee · Edwards Lifesciences, LLC
Key facts
| Original PMA | P100041 |
|---|---|
| Supplement number | S056 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Postapproval Study Protocol - OSB |
| Trade name | SAPIEN THV WITH RETROFLEX FOR INOPERABLE PATIENTS AND WITH RETROFLEX OR ASCENDRA FOR HIGH RISK OPERABLE |
| Generic name | Aortic valve, prosthesis, percutaneously delivered |
| Applicant | Edwards Lifesciences, LLC |
| Product code | NPT |
| Received date | Jul 17, 2014 |
| Decision date | Aug 28, 2014 |
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: