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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
Generic NameHEART-VALVE, MECHANICAL
ApplicantCorcym S.r.l.
Via Crescentino Sn
Saluggia 13040
PMA NumberP900060
Supplement NumberS033
Date Received05/26/2005
Decision Date07/21/2006
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT THE SORIN BIOMEDICA CARDIO, S.R.L. FACILITY IN SALUGGIA, ITALY TO MANUFACTURE PYROLYTIC CARBON COMPONENTS FOR THE CARBOMEDICS PROSTHETIC HEART VALVE, CARBO-SEAL ASCENDING AORTIC PROSTHESIS AND CARBO-SEAL VALSALVA ASCENDING AORTIC PROSTHESIS DEVICES.
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