PROSTHETIC HEART VALVE (CPHV), CARBO-SEAL ASCENDING AORTIC PROSTHESIS (AAP) AND CARBO-SEAL VALSALVA ASCENDING AORTIC PRO
FDA premarket approval P900060/S034 · decided 2005-11-30
Approval details
- PMA number
- P900060
- Supplement
- S034
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROSTHETIC HEART VALVE (CPHV), CARBO-SEAL ASCENDING AORTIC PROSTHESIS (AAP) AND CARBO-SEAL VALSALVA ASCENDING AORTIC PRO
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Corcym S.r.l.
- Date received
- 2005-09-06
- Decision date
- 2005-11-30
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Saluggia
- Statement
- APPROVAL TO SUBSTITUTE AN OUTSIDE VENDOR FOR SPECIFIC METAL COMPONENTS OF THE PROSTHETIC HEART VALVES. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES CARBOMEDICS PROSTHETIC HEART VALVE (CPHV), CARBO-SEAL ASCENDING AORTIC PROSTHESIS (AAP) AND CARBO-SEAL VALSALVA ASCENDING AORTIC PROSTHESIS (AAP).
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