CARBOMEDICS(R) PROSTHETIC HEART VALVE/CARBO-SEAL(R) ASCENDING AORTIC PROSTHESIS
FDA premarket approval P900060/S021 · decided 2000-09-05
Approval details
- PMA number
- P900060
- Supplement
- S021
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CARBOMEDICS(R) PROSTHETIC HEART VALVE/CARBO-SEAL(R) ASCENDING AORTIC PROSTHESIS
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Corcym S.r.l.
- Date received
- 2000-08-07
- Decision date
- 2000-09-05
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Saluggia
- Statement
- CHANGE TO A LARGER CAPACITY CHAMBER USED TO STERILIZE THE SULZER CARBOMEDICS CARBO-SEAL(R) ASCENDING AORTIC PROSTHESIS. THIS LARGER CAPACITY CHAMBER IS LOCATED AT THE FACILITY IDENTIFIED AS SULZER VASCUTEK LOCATED IN SCOTLAND.
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