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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSULZER CARBOMEDICS CARBO-SEAL ASCENDING AORTIC PROSTHESIS
Classification Nameheart-valve, mechanical
Generic Namevalve rotator
ApplicantSULZER CARBOMEDICS, INC.
PMA NumberP900060
Supplement NumberS017
Date Received06/01/1998
Decision Date06/11/1998
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
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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