This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | BJORK-SHILEY CARDIAC VALVE |
| Generic Name | Heart-valve, Mechanical |
| Applicant | SHILEY, INC. |
| Date Received | 1983-08-08 |
| Decision Date | 1984-05-15 |
| PMA | P780008 |
| Supplement | S011 |
| Product Code | LWQ |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SHILEY, INC. 17600 Gillette Ave. p.o. Box 19503 irvine, CA 92714 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P780008 | Original Filing | |
| S015 | 1983-12-08 | |
| S014 | 1983-08-22 | Normal 180 Day Track |
| S013 | 1983-11-21 | |
| S012 | ||
| S011 | 1983-08-08 | |
| S010 | ||
| S009 | ||
| S008 | ||
| S007 | 1982-10-19 | |
| S006 | ||
| S005 | 1981-10-26 | |
| S004 | ||
| S003 | ||
| S002 | ||
| S001 |