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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 NameCARBOMEDICS PROSTHETIC HEART VALVE (CPHV)
Classification Nameheart-valve, mechanical
Generic Namecarbomedics prosthetic heart valve
ApplicantCARBOMEDICS, INC.
PMA NumberP900060
Supplement NumberS029
Date Received06/14/2004
Decision Date07/02/2004
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 
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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