PMA
P110021: EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
FDA PMA · Aortic valve, prosthesis, percutaneously delivered · Edwards Lifesciences, LLC
Key facts
| PMA number | P110021 |
|---|---|
| Trade name | EDWARDS SAPIEN 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 | Oct 19, 2012 |
| Docket number | 12M-1088 |
| Notice date | Nov 7, 2012 |
| Establishment registration | 3008500478 |
| FEI number | 1713910 |
At a glance
- 10–99 Supplements
- Mar 22, 2016 Latest supplement decision
- Yes Withdrawn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: