PMA
P810002: BILEAFLET-CENTER OPENING CARDIAC VALVE
FDA PMA · HEART-VALVE, MECHANICAL · ABBOTT MEDICAL
Key facts
| PMA number | P810002 |
|---|---|
| Trade name | BILEAFLET-CENTER OPENING CARDIAC VALVE |
| Generic name | HEART-VALVE, MECHANICAL |
| Applicant | ABBOTT MEDICAL |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | LWQ |
| Approval date | Dec 17, 1982 |
| Docket number | 83M-0004 |
| Notice date | Mar 1, 1983 |
| Establishment registration | 3007113487 |
| FEI number | 3007113487 |
At a glance
- 100–999 Supplements
- Jun 11, 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- No Withdrawn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: