CARBOMEDICS PROSTHETIC HEART VALVE
FDA premarket approval P900060/S033 · decided 2006-07-21
Approval details
- PMA number
- P900060
- Supplement
- S033
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CARBOMEDICS PROSTHETIC HEART VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Corcym S.r.l.
- Date received
- 2005-05-26
- Decision date
- 2006-07-21
- Days to decision
- 421 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Saluggia
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT THE SORIN BIOMEDICA CARDIO, S.R.L. FACILITY IN SALUGGIA, ITALY TO MANUFACTURE PYROLYTIC CARBON COMPONENTS FOR THE CARBOMEDICS PROSTHETIC HEART VALVE, CARBO-SEAL ASCENDING AORTIC PROSTHESIS AND CARBO-SEAL VALSALVA ASCENDING AORTIC PROSTHESIS DEVICES.
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