PMA supplement
P790018 S030: MEDTRONIC(R) HALL PROSTHETIC HEART VALVE
FDA PMA supplement · Normal 180 Day Track · Medtronic Cardiac Surgery
Key facts
| Original PMA | P790018 |
|---|---|
| Supplement number | S030 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | MEDTRONIC(R) HALL PROSTHETIC HEART VALVE |
| Generic name | HEART-VALVE, MECHANICAL |
| Applicant | Medtronic Cardiac Surgery |
| Product code | LWQ |
| Received date | Mar 13, 1997 |
| Decision date | Sep 29, 1997 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: