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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 FX device
Generic NameAortic valve, prosthesis, percutaneously delivered
ApplicantMedtronic, Inc.
710 Medtronic Pkwy.
Miinneapolis, MN 55432
PMA NumberP130021
Supplement NumberS103
Date Received09/13/2021
Decision Date09/22/2021
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  
The following changes implemented to Evolut FX: 1) relocation of tissue processing worksteps to new controlled environments including introduction of new equipment, systems, and layout changes; 2) implementation of new equipment and process re-sequencing for a delivery catheter system component; 3) dimensional modifications to a measurement tool used for in-process inspection of the delivery catheter; and 4) addition of a new tissue supplier.
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