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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 NumberS020
Date Received07/21/1999
Decision Date06/29/2000
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 USE OF A NITINOL LOCK WIRE AS AN ALTERNATIVE MATERIAL FOR THE SEWING CUFF ATTACHMENT MECHANISM OF THE PRODUCTS LISTED.
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