CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)
FDA premarket approval P900060/S052 · decided 2013-07-25
Approval details
- PMA number
- P900060
- Supplement
- S052
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Corcym S.r.l.
- Date received
- 2013-06-25
- Decision date
- 2013-07-25
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Saluggia
- Statement
- ADDITION OF AN ALTERNATE SUPPLIER FOR THE QUALITY CONTROL INSPECTION OF SILICON CONTENT ON THE CPHV PYC COMPONENTS.
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