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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCARBOMEDICS/CARBO-SEAL ASCENDING& VALSALVA/ORBIS/OPTIFORM HEART VALVES
Classification Nameheart-valve, mechanical
Generic Namecarbomedics prosthetic heart valve
ApplicantSORIN GROUP USA INC.
PMA NumberP900060
Supplement NumberS042
Date Received06/02/2011
Decision Date06/30/2011
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change of a supplier for lock wire components.
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