Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | SULZER CARBOMEDICS CARBO-SEAL ASCENDING AORTIC PROSTHESIS |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | CORCYM S.r.l. Via Crescentino, sn Saluggia 13040 |
PMA Number | P900060 |
Supplement Number | S017 |
Date Received | 06/01/1998 |
Decision Date | 06/11/1998 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order 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 envelopes are transferred to growth medium. |
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