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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 OPEN PIVOT BILEAFLET HEART VALVE
Classification Nameheart-valve, mechanical
Generic Namereplacement heart valve
ApplicantATS MEDICAL, INC.
PMA NumberP990046
Supplement NumberS004
Date Received03/26/2001
Decision Date06/14/2001
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a shelf life extension from 3 years to 5 years.
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