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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; CARBOMEDICS Supra-Annular Prosthetic Heart Valve (Top Hat); ORBIS Prosthetic Heart V
Generic NameHEART-VALVE, MECHANICAL
ApplicantCorcym S.r.l.
Via Crescentino Sn
Saluggia 13040
PMA NumberP900060
Supplement NumberS068
Date Received02/14/2025
Decision Date05/15/2025
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for the introduction of a new supplier of PET fabric, sewing changes impacting the cuff component of CPHV devices, and the removal of the Carbofilm coating from PET fabric
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