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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 NumberS026
Date Received11/24/2017
Decision Date12/21/2017
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  
Addition of a new sterilization site for the Enlite Sensor and the Guardian Sensor (3). The Enlite Sensor is a component of MiniMed 530G System, MiniMed Paradigm Real-Time Revel System, and MiniMed iPro2 CGM System with Enlite Sensor. The Guardian Sensor (3) is a component of MiniMed 630G System with SmartGuard and the MiniMed 670G System.
Post-Approval StudyShow Report Schedule and Study Progress
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