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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
Applicant
MEDTRONIC MINIMED
18000 devonshire street
northridge, CA 91325-1219
PMA NumberP160007
Supplement NumberS033
Date Received11/29/2019
Decision Date12/19/2019
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Update sterilization procedure for the Enlite Sensor and Guardian Sensor (3). The Enlite Sensor and Guardian Sensor (3) are components of the MiniMed 530G, 630G, and 670G Systems; the Paradigm Real-Time Revel System; the iPro2 CGM System; and the Guardian Connect System.
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