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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 VALSALVA ASCENDING AORTIC PROTHESIS
Classification Nameheart-valve, mechanical
Generic Namecarbomedics prosthetic heart valve
ApplicantSULZER CARBOMEDICS, INC.
PMA NumberP900060
Supplement NumberS025
Date Received05/20/2003
Decision Date08/01/2003
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an extension of shelf life from one to five years for the carbomedicscarbo-seal valsalva ascending aortic prosthesis (aap).
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