PMA
P860057: EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES
FDA PMA · Replacement Heart-valve · Edwards Lifesciences, LLC
Key facts
| PMA number | P860057 |
|---|---|
| Trade name | EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES |
| Generic name | Replacement Heart-valve |
| Applicant | Edwards Lifesciences, LLC |
| Owner/operator | Edwards Lifesciences LLC |
| Product code | DYE |
| Approval date | Sep 26, 1991 |
| Docket number | 91M-0397 |
| Notice date | Nov 12, 1991 |
| Establishment registration | 2015691 |
| FEI number | 2015691 |
At a glance
- 100–999 Supplements
- Jul 29, 2026 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 100–999 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: