CARBOMEDICS(R) PROSTHETIC HEART VALVE (CPHV)
FDA premarket approval P900060/S007 · decided 1995-10-26
Approval details
- PMA number
- P900060
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CARBOMEDICS(R) PROSTHETIC HEART VALVE (CPHV)
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Corcym S.r.l.
- Date received
- 1994-12-20
- Decision date
- 1995-10-26
- Days to decision
- 310 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Saluggia
- Statement
- APPROVAL TO ADD AN ADDITIONAL STERILIZATION PROTOCOL TO THE CPHV INSTRUMENTATION INSTRUCTIONS FOR USE
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