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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
Generic NameAutomated insulin dosing device system, single hormonal control
ApplicantMedtronic Minimed, Inc.
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP160017
Supplement NumberS081
Date Received01/08/2020
Decision Date01/31/2020
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  
New sterilization site for the sterilization of the Guardian Sensor (3) continuous glucose monitoring sensors that are manufactured at Medtronic Puerto Rico Operations Company. The Guardian Sensor (3) is a component of the MiniMed 630G system, the Guardian Connect system, and the MiniMed 670G system.
Post-Approval StudyShow Report Schedule and Study Progress
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