PMA
P040021: SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE
FDA PMA · Heart-valve, non-allograft tissue · ABBOTT MEDICAL
Key facts
| PMA number | P040021 |
|---|---|
| Trade name | SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE |
| Generic name | Heart-valve, non-allograft tissue |
| Applicant | ABBOTT MEDICAL |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | LWR |
| Approval date | Aug 5, 2005 |
| Docket number | 05M-0321 |
| Notice date | Aug 24, 2005 |
| Establishment registration | 3007113487 |
| FEI number | 3007113487 |
At a glance
- 10–99 Supplements
- Sep 18, 2026 Latest supplement decision
- No Withdrawn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: