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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(R) PROSTHETIC HEART VALVE (CPHV)
Classification Nameheart-valve, mechanical
Generic Nameprosthetic heart valve
ApplicantCARBOMEDICS, INC.
PMA NumberP900060
Supplement NumberS007
Date Received12/20/1994
Decision Date10/26/1995
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to add an additional sterilization protocol to the cphv instrumentation instructions for use.
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