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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 NumberS026
Date Received06/27/2003
Decision Date07/25/2003
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 OF THE PAPER USED IN THE MANUFACTURE OF THE VENT COVERS INCLUDED IN THE PACKAGING OF THE CARBOMEDICS PROSTHETIC HEART VALVE (CPHV).
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