PMA
P870077: CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS
FDA PMA · Replacement Heart-valve · Edwards Lifesciences, LLC
Key facts
| PMA number | P870077 |
|---|---|
| Trade name | CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS |
| Generic name | Replacement Heart-valve |
| Applicant | Edwards Lifesciences, LLC |
| Owner/operator | Edwards Lifesciences LLC |
| Product code | DYE |
| Approval date | Sep 25, 1991 |
| Docket number | 91M-0410 |
| Notice date | Nov 12, 1991 |
| Establishment registration | 2015691 |
| FEI number | 2015691 |
At a glance
- 10–99 Supplements
- May 19, 2014 Latest supplement decision
- Yes Withdrawn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: