PMA supplement
P900060 S064: Carbomedics® Prosthetic Heart Valve, Carbomedics® Supra-annular Prosthetic Heart Valve (Top Hat), Carbo-Seal® Ascending
FDA PMA supplement · 30-Day Notice · Corcym S.r.l.
Key facts
| Original PMA | P900060 |
|---|---|
| Supplement number | S064 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Carbomedics® Prosthetic Heart Valve, Carbomedics® Supra-annular Prosthetic Heart Valve (Top Hat), Carbo-Seal® Ascending |
| Generic name | HEART-VALVE, MECHANICAL |
| Applicant | Corcym S.r.l. |
| Product code | LWQ |
| Received date | Feb 7, 2022 |
| Decision date | Mar 7, 2022 |
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: