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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 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.
 
DeviceCARBOMEDICS PROSTHETIC HEART VALVE (CPHV)
Generic NameHEART-VALVE, MECHANICAL
ApplicantCORCYM S.r.l.
Via Crescentino, sn
Saluggia 13040
PMA NumberP900060
Supplement NumberS029
Date Received06/14/2004
Decision Date07/02/2004
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE IN THE MANUFACTURING PROCESS TO THE STERILIZATION PARAMETRIC RELEASE METHOD, WHICH INVOLVES STERILE PRODUCT RELEASE BASED ON CONFORMANCE TO PRE-DEFINED STERILIZATION PARAMETERS RATHER THAN A RELEASE BASED ON DEMONSTRATING NO GROWTH IN A BIOLOGICAL INDICATOR.
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