PMA supplement
P900060 S068: CARBOMEDICS Prosthetic Heart Valve; CARBOMEDICS Supra-Annular Prosthetic Heart Valve (Top Hat); ORBIS Prosthetic Heart V
FDA PMA supplement · Normal 180 Day Track · Corcym S.r.l.
Key facts
| Original PMA | P900060 |
|---|---|
| Supplement number | S068 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | CARBOMEDICS Prosthetic Heart Valve; CARBOMEDICS Supra-Annular Prosthetic Heart Valve (Top Hat); ORBIS Prosthetic Heart V |
| Generic name | HEART-VALVE, MECHANICAL |
| Applicant | Corcym S.r.l. |
| Product code | LWQ |
| Received date | Feb 14, 2025 |
| Decision date | May 15, 2025 |
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: