SULZER CARBOMEDICS CARBO-SEAL ASCENDING AORTIC PROSTHESIS
FDA premarket approval P900060/S017 · decided 1998-06-11
Approval details
- PMA number
- P900060
- Supplement
- S017
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SULZER CARBOMEDICS CARBO-SEAL ASCENDING AORTIC PROSTHESIS
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Corcym S.r.l.
- Date received
- 1998-06-01
- Decision date
- 1998-06-11
- Days to decision
- 10 days
- Decision code
- OK30
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Saluggia
- Statement
- Requested a modification in the type of biological indicator used in the sterility release of the Carbo-Seal AAP from the AMSCO Spordex Bacillus subtilis globigii spore strips to the 3M Healthcare Attest Bacillus subtilis globigii self-contained biological indicator. The stzated reason for the change is to reduce the incubation period from seven to two days, and to reduce the change of operator error by eliminating the possibilitry of contaimination that may occur when spore strips in glassine e
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