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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 HEART VALVE
Generic NameHEART-VALVE, MECHANICAL
ApplicantMedtronic Ats Medical, Inc.
3800 Annapolis Ln., Suite 175
Minneapolis, MN 55447
PMA NumberP990046
Supplement NumberS032
Date Received03/28/2013
Decision Date06/07/2013
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED IN MINNEAPOLIS,MINNESOTA.
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