This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the monostrut(tm) cardiac valve prosthesis. This device is indicated for the replacement of malfunctioning native or prosthetic mitral (sizes 27, 29, 31, and 33 mm) or aortic (sizes 21, 23, 25, 27, 29, 31, and 33 mm) heart valves.
| Device | MONOSTRUT CARDIAC VALVE PROSTHESIS |
| Generic Name | Heart-valve, Mechanical |
| Applicant | ALLIANCE MEDICAL TECHNOLOGIES, INC. |
| Date Received | 1997-01-24 |
| Decision Date | 1997-09-30 |
| Notice Date | 1998-04-07 |
| PMA | P970002 |
| Supplement | S |
| Product Code | LWQ |
| Docket Number | 98M-0200 |
| Advisory Committee | Cardiovascular |
| 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 |