PMA supplement
P040021 S011: SJM BIOCOR, BIOCOR SUPRA, EPIC AND EPIC SUPRA HEART VALVES
FDA PMA supplement · Normal 180 Day Track No User Fee · ABBOTT MEDICAL
Key facts
| Original PMA | P040021 |
|---|---|
| Supplement number | S011 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | SJM BIOCOR, BIOCOR SUPRA, EPIC AND EPIC SUPRA HEART VALVES |
| Generic name | Heart-valve, non-allograft tissue |
| Applicant | ABBOTT MEDICAL |
| Product code | LWR |
| Received date | Aug 17, 2009 |
| Decision date | Oct 2, 2009 |
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: