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: Simplera Sync; Guardian Sensor (3) Transfer to MPROC; MiniMed 780G System with G4S
• 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: S138
• Date Received: 06/22/2026
• Decision Date: 07/21/2026
• Product Code: OZP
• Advisory Committee: Clinical Chemistry
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
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