PMA
P790007: HANCOCK MODIFIED ORIFICE BIOPROSTHESIS
FDA PMA · Heart-valve, non-allograft tissue · Medtronic Heart Valves
Key facts
| PMA number | P790007 |
|---|---|
| Trade name | HANCOCK MODIFIED ORIFICE BIOPROSTHESIS |
| Generic name | Heart-valve, non-allograft tissue |
| Applicant | Medtronic Heart Valves |
| Owner/operator | Medtronic, Inc. |
| Product code | LWR |
| Approval date | Nov 15, 1979 |
| Notice date | Aug 8, 1980 |
| Establishment registration | 2025587 |
| FEI number | 2022036 |
At a glance
- 10–99 Supplements
- Apr 16, 2025 Latest supplement decision
- No Withdrawn
- No 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: