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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
DeviceMiniMed 780G System
Generic NameAutomated insulin dosing device system, single hormonal control
PMA NumberP160017
Supplement NumberS091
Date Received02/22/2021
Decision Date04/21/2023
Product Code OZP 
Docket Number 23M-1596
Notice Date 04/25/2023
Advisory Committee Clinical Chemistry
Clinical TrialsNCT03959423
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval of the MiniMed 780G System for modifications to the SmartGuard Technology and for expanding the indications for use to include the Guardian 4 Sensor.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Post-Approval StudyShow Report Schedule and Study Progress