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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceOPEN PIVOT AORTIC VALVED GRAFT
Generic NameHEART-VALVE, MECHANICAL
ApplicantMEDTRONIC ATS MEDICAL, INC.
3800 ANNAPOLIS LANE, SUITE 175
PLYMOUTH, MN 55447
PMA NumberP990046
Supplement NumberS027
Date Received03/08/2012
Decision Date04/03/2012
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR ADDING TEXT TO THE OPEN PIVOT AORTIC VALVED GRAFT INSTRUCTIONS FOR USE (IFU) TO STRENGTHEN THE CAUTERIZATION PRECAUTION STATEMENT.
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