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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 Mechanical Valve (OPHV), Open Pivot Aortic Valved Graft (AVG)
Generic NameHEART-VALVE, MECHANICAL
ApplicantMedtronic Ats Medical, Inc.
3800 Annapolis Ln., Suite 175
Minneapolis, MN 55447
PMA NumberP990046
Supplement NumberS062
Date Received02/08/2022
Decision Date03/10/2022
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
New yarn extrusion and compounding suppliers and automation of the scouring process for the polyester yarn components.
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