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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 with SmartGuard
Generic Nameautomated insulin dosing device system, single hormonal control
18000 devonshire street
northridge, CA 91325
PMA NumberP160017
Supplement NumberS024
Date Received10/10/2017
Decision Date11/07/2017
Product Code OZP 
Advisory Committee Clinical Chemistry
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
New electroplating machine to increase manufacturing capacity for the Guardian Sensor (3) continuous glucose monitoring sensor. The Guardian Sensor (3) is a component of the MiniMed 630G and MiniMed 670G systems.