PMA
P850006: DUROMEDICS BILEAFLET HEART VALVE
FDA PMA · HEART-VALVE, MECHANICAL · Edwards Lifesciences, LLC
Key facts
| PMA number | P850006 |
|---|---|
| Trade name | DUROMEDICS BILEAFLET HEART VALVE |
| Generic name | HEART-VALVE, MECHANICAL |
| Applicant | Edwards Lifesciences, LLC |
| Owner/operator | Edwards Lifesciences LLC |
| Product code | LWQ |
| Approval date | Aug 29, 1986 |
| Docket number | 86M-0377 |
| Notice date | Sep 26, 1986 |
| Establishment registration | 2015691 |
| FEI number | 2015691 |
At a glance
- None Supplements
- Aug 29, 1986 Latest supplement decision
- Yes Withdrawn
- No Summary of safety and effectiveness on file
- None 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: