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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 NameOPEN PIVOT BI-LEAFLET HEART VALVE
Classification Nameheart-valve, mechanical
Generic Namereplacement heart valve
ApplicantATS MEDICAL, INC.
PMA NumberP990046
Supplement NumberS019
Date Received09/26/2008
Decision Date04/24/2009
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason pas protocal supplement osb
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval study protocol.
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