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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.
 
DeviceATS OPEN PIVOT? BILEAFLET HEART VALVE 35 MM MITRAL VALVE
Generic NameHEART-VALVE, MECHANICAL
ApplicantMEDTRONIC ATS MEDICAL, INC.
3800 ANNAPOLIS LANE, SUITE 175
PLYMOUTH, MN 55447
PMA NumberP990046
Supplement NumberS017
Date Received01/30/2007
Decision Date07/23/2007
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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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