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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 NumberS053
Date Received01/23/2014
Decision Date02/20/2014
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  
MODIFIED IN-PROCESS INSPECTION FOR DETECTION OF MATERIAL DEPOSITS.
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