PMA supplement
P900060 S021: CARBOMEDICS(R) PROSTHETIC HEART VALVE/CARBO-SEAL(R) ASCENDING AORTIC PROSTHESIS
FDA PMA supplement · 30-Day Notice · Corcym S.r.l.
Key facts
| Original PMA | P900060 |
|---|---|
| Supplement number | S021 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | CARBOMEDICS(R) PROSTHETIC HEART VALVE/CARBO-SEAL(R) ASCENDING AORTIC PROSTHESIS |
| Generic name | HEART-VALVE, MECHANICAL |
| Applicant | Corcym S.r.l. |
| Product code | LWQ |
| Received date | Aug 7, 2000 |
| Decision date | Sep 5, 2000 |
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: