PMA
P060025: ATS 3F AORTIC BIOPROSTHESIS
FDA PMA · Heart-valve, non-allograft tissue · Medtronic, Inc.
Key facts
| PMA number | P060025 |
|---|---|
| Trade name | ATS 3F AORTIC BIOPROSTHESIS |
| Generic name | Heart-valve, non-allograft tissue |
| Applicant | Medtronic, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | LWR |
| Approval date | Oct 30, 2008 |
| Docket number | 08M-0594 |
| Notice date | Nov 14, 2008 |
| Establishment registration | 3001504994 |
| FEI number | 3001504994 |
At a glance
- 10–99 Supplements
- Aug 21, 2019 Latest supplement decision
- Yes Withdrawn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: