PMA supplement
P780008 S007: BJORK-SHILEY CARDIAC VALVE
FDA PMA supplement · Shiley, Inc.
Key facts
| Original PMA | P780008 |
|---|---|
| Supplement number | S007 |
| Trade name | BJORK-SHILEY CARDIAC VALVE |
| Generic name | HEART-VALVE, MECHANICAL |
| Applicant | Shiley, Inc. |
| Product code | LWQ |
| Received date | Oct 19, 1982 |
| Decision date | May 20, 1983 |
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: