PMA
P980043: HANCOCK II PORCINE BIOPROSTHESIS
FDA PMA · Replacement Heart-valve · Medtronic, Inc.
Key facts
| PMA number | P980043 |
|---|---|
| Trade name | HANCOCK II PORCINE BIOPROSTHESIS |
| Generic name | Replacement Heart-valve |
| Applicant | Medtronic, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | DYE |
| Approval date | Sep 28, 1999 |
| Docket number | 99M-4279 |
| Notice date | Oct 15, 1999 |
| Establishment registration | 3001504994 |
| FEI number | 3001504994 |
At a glance
- 10–99 Supplements
- Feb 12, 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- No Withdrawn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: