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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 NameATS AVG (AORTIC VALVED GRAFT)
Classification Nameheart-valve, mechanical
Generic Namereplacement heart valve
ApplicantATS MEDICAL, INC.
PMA NumberP990046
Supplement NumberS009
Date Received08/28/2003
Decision Date09/23/2003
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the sterilization validation protocol for the ats avg (aortic valved graft).
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