PMA
P990064: MEDTRONIC MOSAIC PORCINE BIOPROSTHETIC HEART VALVE
FDA PMA · Replacement Heart-valve · Medtronic, Inc.
Key facts
| PMA number | P990064 |
|---|---|
| Trade name | MEDTRONIC MOSAIC PORCINE BIOPROSTHETIC HEART VALVE |
| Generic name | Replacement Heart-valve |
| Applicant | Medtronic, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | DYE |
| Approval date | Jul 14, 2000 |
| Docket number | 00M-1416 |
| Notice date | Aug 3, 2000 |
| Establishment registration | 3001504994 |
| FEI number | 3001504994 |
At a glance
- 10–99 Supplements
- Mar 3, 2026 Latest supplement decision
- No Withdrawn
- Yes 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: