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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.
DeviceGuardian Connect system
Generic Namesensor, glucose, invasive
18000 devonshire street
northridge, CA 91325-1219
PMA NumberP160007
Supplement NumberS039
Date Received11/03/2020
Decision Date12/01/2020
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Manufacturing changes related to bioburden testing for the Enlite Sensor and Guardian Sensor (3). The Enlite Sensor is component of the MiniMed 530G System, the MiniMed 630G System, the Paradigm Real-Time Revel System, and the iPro2 CGM System. The Guardian Sensor (3) is component of the MiniMed 670G System, the Guardian Connect System, and the MiniMed 630G System with SmartGuard.