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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(R) PROSTHETIC HEART VALVE/CARBO-SEAL(R) ASCENDING AORTIC PROSTHESIS
Generic NameHEART-VALVE, MECHANICAL
ApplicantCorcym S.r.l.
Via Crescentino Sn
Saluggia 13040
PMA NumberP900060
Supplement NumberS021
Date Received08/07/2000
Decision Date09/05/2000
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE TO A LARGER CAPACITY CHAMBER USED TO STERILIZE THE SULZER CARBOMEDICS CARBO-SEAL(R) ASCENDING AORTIC PROSTHESIS. THIS LARGER CAPACITY CHAMBER IS LOCATED AT THE FACILITY IDENTIFIED AS SULZER VASCUTEK LOCATED IN SCOTLAND.
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