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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 35 MM MITRAL VALVE
Classification Nameheart-valve, mechanical
Generic Namereplacement heart valve
ApplicantATS MEDICAL, INC.
PMA NumberP990046
Supplement NumberS017
Date Received01/30/2007
Decision Date07/23/2007
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a cuff change to add the 35 mm mitral valve to the approved mitral valve sizes.
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