PMA supplement
P830039 S007: OMNICARBON CARDIAC VALVE PROSTHESIS
FDA PMA supplement · Panel Track · Medical Cv, Inc.
Key facts
| Original PMA | P830039 |
|---|---|
| Supplement number | S007 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | OMNICARBON CARDIAC VALVE PROSTHESIS |
| Generic name | HEART-VALVE, MECHANICAL |
| Applicant | Medical Cv, Inc. |
| Product code | LWQ |
| Received date | Oct 24, 1996 |
| Decision date | Jul 26, 2001 |
| Docket number | 01M-0380 |
| Notice date | Sep 5, 2001 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: