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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.
 
DeviceMedtronic MiniMed 670G System (MM670G), Medtronic MiniMed 770G System (MM770G)
Generic NameAutomated insulin dosing device system, single hormonal control
ApplicantMedtronic Minimed, Inc.
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP160017
Supplement NumberS109
Date Received02/13/2023
Decision Date03/13/2023
Product Code OZP 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT02130284
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Manufacturing change to expand the welding parameters used when manufacturing the pump case assembly. The pump case assembly is a component of the MiniMed 630G, MiniMed 670G, and MiniMed 770G systems.
Post-Approval StudyShow Report Schedule and Study Progress
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