PMA
P790018: MEDTRONIC(R) HALL PROSTHETIC HEART VALVE
FDA PMA · HEART-VALVE, MECHANICAL · Medtronic Cardiac Surgery
Key facts
| PMA number | P790018 |
|---|---|
| Trade name | MEDTRONIC(R) HALL PROSTHETIC HEART VALVE |
| Generic name | HEART-VALVE, MECHANICAL |
| Applicant | Medtronic Cardiac Surgery |
| Owner/operator | Medtronic, Inc. |
| Product code | LWQ |
| Approval date | Dec 23, 1981 |
| Docket number | 82M-0003 |
| Notice date | Jan 29, 1982 |
| Establishment registration | 3015544746 |
| FEI number | 3003418152 |
At a glance
- 10–99 Supplements
- Dec 18, 2009 Latest supplement decision
- Yes Withdrawn
- No Summary of safety and effectiveness on file
- None 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: