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 | MONOSTRUT CARDIAC VALVE PROSTHESIS |
| Generic Name | Heart-valve, Mechanical |
| Applicant | ALLIANCE MEDICAL TECHNOLOGIES, INC. |
| Date Received | 1998-03-02 |
| Decision Date | 1998-03-23 |
| PMA | P970002 |
| Supplement | S001 |
| Product Code | LWQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ALLIANCE MEDICAL TECHNOLOGIES, INC. 17590 Gillette Ave. irvine,, CA 92614 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P970002 | Original Filing | |
| S001 | 1998-03-02 | 30-day Notice |