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: MiniMed 780G System
• Generic Name: Automated insulin dosing device system, single hormonal control
• Applicant: Medtronic Minimed, Inc.; 18000 Devonshire St.; Northridge, CA 91325
• PMA Number: P160017
• Supplement Number: S140
• Date Received: 09/01/2026
• Decision Date: 09/29/2026
• Product Code: OZP
• Advisory Committee: Clinical Chemistry
• 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 revised protocol for the post-approval study (PAS)