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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.
 
DeviceEvolut PRO+ TAV of the Evolut PRO+ System, Evolut PRO TAV of the Evolut PRO System, Evolut R TAV of the Evolut R System
Generic NameAortic valve, prosthesis, percutaneously delivered
ApplicantMedtronic, Inc.
710 Medtronic Pkwy.
Miinneapolis, MN 55432
PMA NumberP130021
Supplement NumberS079
Date Received07/08/2020
Decision Date07/13/2020
Product Code NPT 
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  
Change in tissue cutting parameters for the transcatheter aortic valves (TAVs) of the Evolut PRO, PRO+, and R systems.
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