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: HeartWare HVAD System
• Generic Name: Ventricular (assist) bypass
• Applicant: Medtronic; 8200 Coral Sea St. N.E; Mounds View, MN 55112
• PMA Number: P100047
• Supplement Number: S114
• Date Received: 10/30/2017
• Decision Date: 03/15/2018
• Product Code: DSQ
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

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