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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 Nameheart valve
ApplicantCARBOMEDICS, INC.
PMA NumberP900060
Supplement NumberS005
Date Received04/23/1994
Decision Date07/08/1994
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
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