PMA supplement
P040021 S004: SJM EPIC VALVE AND SJM EPIC SUPRA VALVE
FDA PMA supplement · Panel Track · ABBOTT MEDICAL
Key facts
| Original PMA | P040021 |
|---|---|
| Supplement number | S004 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | SJM EPIC VALVE AND SJM EPIC SUPRA VALVE |
| Generic name | Replacement Heart-valve |
| Applicant | ABBOTT MEDICAL |
| Product code | DYE |
| Received date | Sep 29, 2006 |
| Decision date | Nov 15, 2007 |
| Docket number | 08M-0084 |
| Notice date | Feb 5, 2008 |
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: