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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
ApplicantMEDTRONIC MINIMED
18000 DEVONSHIRE STREET
NORTHRIDGE, CA 91325-1219
PMA NumberP160007
Supplement NumberS015
Date Received02/11/2019
Decision Date03/11/2019
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  
Additional equipment for the production of Tyvek lid and thermoformed tray used for the packaging of Guardian (3) and Enlite sensors. The Guardian Sensor (3) is a component of of the Medtronic MiniMed 670G, MiniMed 630G with SmartGuard and Guardian Connect Systems and the Enlite Sensor is a component of the Medtronic MiniMed 530G, MiniMed 630G with SmartGuard, iPro2 and Paradigm REAL-Time Revel Systems.
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