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 MiniMed 630G System with Guardian Sensor (3); Guardian Sensor (3) Transfer to MPROC
• Generic Name: Automated insulin dosing , threshold suspend
• Applicant: Medtronic Minimed; 18000 Devonshire St.; Northridge, CA 91325
• PMA Number: P150001
• Supplement Number: S111
• Date Received: 06/22/2026
• Decision Date: 07/21/2026
• Product Code: OZO
• 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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