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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 NumberS052
Date Received10/15/2018
Decision Date11/14/2018
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 facility move at one of Medtronics tier one supplier for the manual needle-hub assembly and one-press serter base component. The one-press serter is a component of the Enlite Sensor and Guardian Sensor (3). The needle-hub assembly component is used in the Medtronic Enlite Sensor and the Guardian Sensor (3). The Enlite Sensor is a component of the Medtronic MiniMed 530G, 630G with SmartGuard, Paradigm Real-Time Revel System and iPro2 Continuous Glucose Monitoring Systems and Guardian Sensor (3) are components of the Medtronic MiniMed 670G and MiniMed 630G Continuous Glucose Monitoring Systems
Post-Approval StudyShow Report Schedule and Study Progress
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