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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 Ln., Suite 175
Minneapolis, MN 55447
PMA NumberP990046
Supplement NumberS059
Date Received05/06/2021
Decision Date07/29/2021
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for changes to the inner packaging design and extension of the shelf life.
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