MONOSTRUT CARDIAC VALVE PROSTHESIS
FDA premarket approval P970002 · decided 1997-09-30
Approval details
- PMA number
- P970002
- Trade name
- MONOSTRUT CARDIAC VALVE PROSTHESIS
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Alliance Medical Technologies, Inc.
- Date received
- 1997-01-24
- Decision date
- 1997-09-30
- Days to decision
- 249 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine,, CA
- Statement
- 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.
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