PMA supplement
P810002 S039: MECHANICAL HEART VALVE SJM(R) MASTER SERIES (EXPANDED SEWING CUFF)
FDA PMA supplement · Normal 180 Day Track · ABBOTT MEDICAL
Key facts
| Original PMA | P810002 |
|---|---|
| Supplement number | S039 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | MECHANICAL HEART VALVE SJM(R) MASTER SERIES (EXPANDED SEWING CUFF) |
| Generic name | HEART-VALVE, MECHANICAL |
| Applicant | ABBOTT MEDICAL |
| Product code | LWQ |
| Received date | Sep 11, 1995 |
| Decision date | Mar 21, 1996 |
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: