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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 670G System
Generic NameAutomated insulin dosing device system, single hormonal control
ApplicantMedtronic Minimed, Inc.
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP160017
Supplement NumberS020
Date Received09/27/2017
Decision Date12/08/2017
Product Code OZP 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT02130284
Supplement TypeNormal 180 Day 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 for 1) minor design changes to the electronics board stack used in the 670G insulin pump; 2) a new supplier for the electronics board stack; 3) an updated pump software version; and 4) an extension to the 670G insulin pump shelf life from 185 days to 1095 days.
Post-Approval StudyShow Report Schedule and Study Progress
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