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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(TM) EVOLUT(TM) R SYSTEM
Generic NameAortic valve, prosthesis, percutaneously delivered
ApplicantMedtronic, Inc.
710 Medtronic Pkwy.
Miinneapolis, MN 55432
PMA NumberP130021
Supplement NumberS028
Date Received01/13/2017
Decision Date04/11/2017
Product Code NPT 
Advisory Committee Cardiovascular
Clinical TrialsNCT02207569
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for an alternative material for use in the EnVeo R Delivery Catheter System and alignment of the capsule fuse process across delivery system models.
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