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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.
 
DeviceParadigm Real-Time System and Paradigm Real-Time Revel System
Generic Namesensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
18000 devonshire st
northridge, CA 91325
PMA NumberP980022
Supplement NumberS208
Date Received07/15/2019
Decision Date08/14/2019
Product Codes OYC 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  
Automation of an inspection method at a contract manufacturer used during the packaging of components for the MiniLink REAL-Time transmitter, Guardian Link Transmitter, Guardian Link (3) Transmitter, Guardian Connect System, and iPro2 Recorder. The MiniLink REAL-Time transmitter is a component of the Minimed 530g System, Paradigm REAL-Time Revel System, and the Paradigm REAL-Time System. The Guardian Link Transmitter is a component of the Minimed 630G Insulin Pump System. The Guardian Link (3) Transmitter is a component of the MiniMed 670G System. The Guardian Link Transmitter is a component of the Medtronic MiniMed 630G Insulin Pump System. The Guardian Connect Transmitter is a component of the Guardian Connect System. The iPro2 Recorder is a component of the Ipro2 Continuous Glucose Monitoring System with Enlite Sensor.
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