PMA
P970031: MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS
FDA PMA · Heart-valve, non-allograft tissue · Medtronic, Inc.
Key facts
| PMA number | P970031 |
|---|---|
| Trade name | MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS |
| Generic name | Heart-valve, non-allograft tissue |
| Applicant | Medtronic, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | LWR |
| Approval date | Nov 26, 1997 |
| Docket number | 98M-0906 |
| Establishment registration | 2025587 |
| FEI number | 2025587 |
At a glance
- 10–99 Supplements
- Feb 12, 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- No Withdrawn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: