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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.
DeviceMedtronic CoreValve Evolut PRO System
Generic Nameaortic valve, prosthesis, percutaneously delivered
ApplicantMedtronic, Inc.
710 medtronic parkway
minneapolis,, MN 55432
PMA NumberP130021
Supplement NumberS029
Date Received02/06/2017
Decision Date03/20/2017
Product Code NPT 
Advisory Committee Cardiovascular
Clinical TrialsNCT02738853
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a design iteration of the 23, 26, and 29 mm Medtronic CoreValve Evolut R System. The new components include the CoreValve Evolut PRO Transcatheter Aortic Valves, models EVOLUTPRO-23-US, EVOLUTPRO-26-US, and EVOLUTPRO-29-US, and the EnVeo R Loading Systems, models LS-MDT2-23-US and LS-MDT2-2629-US.
Post-Approval StudyShow Report Schedule and Study Progress