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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 3F AORTIC BIOPROSTHESIS
Classification Nameheart-valve, non-allograft tissue
ApplicantATS MEDICAL, INC.
PMA NumberP060025
Supplement NumberS004
Date Received02/09/2009
Decision Date02/19/2009
Product Code
LWR[ Registered Establishments with LWR ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the tissue fixation process.
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