CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)
FDA premarket approval P900060/S009 · decided 1995-08-14
Approval details
- PMA number
- P900060
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Corcym S.r.l.
- Date received
- 1995-01-19
- Decision date
- 1995-08-14
- Days to decision
- 207 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Saluggia
- Statement
- USE OF A MODIFIED VALVE HOLDER USED AS AN ACCESSORY WITH THE CARBOMEDICS PROSTHETIC HEART VALVE, MODELS A500, R500, M700, & S500
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