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: Medtronic CoreValve System
• Generic Name: Aortic valve, prosthesis, percutaneously delivered
• Applicant: Medtronic, Inc.; 710 Medtronic Pkwy.; Miinneapolis, MN 55432
• PMA Number: P130021
• Supplement Number: S034
• Date Received: 03/09/2017
• Decision Date: 05/09/2017
• Product Code: NPT
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol - OSB
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for changes to the protocol for the post-approval study (PAS) protocol.