Premarket Approval (PMA)

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.

• Device: CoreValve Evolut R and Evolut PRO System
• Generic Name: Aortic valve, prosthesis, percutaneously delivered
• Applicant: Medtronic, Inc.; 710 Medtronic Pkwy.; Miinneapolis, MN 55432
• PMA Number: P130021
• Supplement Number: S080
• Date Received: 07/10/2020
• Decision Date: 10/05/2020
• Product Code: NPT
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for a site change for packaging and labeling rework processes.