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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.
 
DeviceEnVeo PRO Delivery Catheter System, EnVeo R Delivery Catheter System, Evolut PRO+ Delivery Catheter System, Evolut FX De
Generic NameAortic valve, prosthesis, percutaneously delivered
ApplicantMedtronic, Inc.
710 Medtronic Pkwy.
Miinneapolis, MN 55432
PMA NumberP130021
Supplement NumberS114
Date Received03/29/2022
Decision Date03/31/2022
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  
to add an alternative supplier for the packaging tray used in the EnVeo R, EnVeo PRO, Evolut PRO+, and Evolut FX delivery systems
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