PMA
P990046: ATS OPEN PIVOT BILEAFLET HEART VALVE
FDA PMA · HEART-VALVE, MECHANICAL · Medtronic Ats Medical, Inc.
Key facts
| PMA number | P990046 |
|---|---|
| Trade name | ATS OPEN PIVOT BILEAFLET HEART VALVE |
| Generic name | HEART-VALVE, MECHANICAL |
| Applicant | Medtronic Ats Medical, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | LWQ |
| Approval date | Oct 13, 2000 |
| Docket number | 00M-1570 |
| Notice date | Oct 20, 2000 |
| Establishment registration | 3008592544 |
| FEI number | 3008592544 |
At a glance
- 10–99 Supplements
- Nov 7, 2023 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- No Withdrawn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: