CARBOMEDICS PROSTETIC HEART VALVE (CPHV)
FDA premarket approval P900060/S030 · decided 2005-04-08
Approval details
- PMA number
- P900060
- Supplement
- S030
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CARBOMEDICS PROSTETIC HEART VALVE (CPHV)
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Corcym S.r.l.
- Date received
- 2005-01-27
- Decision date
- 2005-04-08
- Days to decision
- 71 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Saluggia
- Statement
- APPROVAL FOR A CHANGE IN THE LOCK WIRE FABRICATION FOR THE CARBOMEDICS PROSTHETIC HEART VALVE.
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