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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 System, Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System
Generic NameAortic valve, prosthesis, percutaneously delivered
ApplicantMedtronic, Inc.
710 Medtronic Pkwy.
Miinneapolis, MN 55432
PMA NumberP130021
Supplement NumberS151
Date Received11/30/2023
Decision Date12/23/2023
Product Code NPT 
Advisory Committee Cardiovascular
Clinical TrialsNCT01586910
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the revised protocols for the post-approval studies outlined in the approval orders for P130021/S033 and P130021/S058.
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