PMA
P130009: EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES
FDA PMA · Aortic valve, prosthesis, percutaneously delivered · Edwards Lifesciences, LLC
Key facts
| PMA number | P130009 |
|---|---|
| Trade name | EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES |
| Generic name | Aortic valve, prosthesis, percutaneously delivered |
| Applicant | Edwards Lifesciences, LLC |
| Owner/operator | Edwards Lifesciences LLC |
| Product code | NPT |
| Approval date | Jun 16, 2014 |
| Docket number | 14M-0874 |
| Notice date | Jul 15, 2014 |
| Establishment registration | 2015691 |
| FEI number | 2015691 |
At a glance
- 100–999 Supplements
- Mar 19, 2021 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: