MONOSTRUT CARDIAC VALVE PROSTHESIS
FDA premarket approval P970002/S001 · decided 1998-03-23
Approval details
- PMA number
- P970002
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MONOSTRUT CARDIAC VALVE PROSTHESIS
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Alliance Medical Technologies, Inc.
- Date received
- 1998-03-02
- Decision date
- 1998-03-23
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine,, CA
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