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U.S. Department of Health and Human Services

Devices@FDA
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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 770G System
Generic NameAutomated insulin dosing device system, single hormonal control
ApplicantMedtronic Minimed, Inc.
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP160017
Supplement NumberS076
Date Received11/01/2019
Decision Date08/31/2020
Product Code OZP 
Docket Number 20M-1838
Notice Date 09/02/2020
Advisory Committee Clinical Chemistry
Clinical TrialsNCT02130284
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval of the MiniMed 770G System to expand the indications for use to use users down to 2 years old and to update the pump communication protocol to Bluetooth Low Energy (BLE).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
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