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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 iPro2 CGM System with Enlite Sensor
Generic NameSensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
18000 DEVONSHIRE ST
NORTHRIDGE, CA 91325
PMA NumberP150029
Supplement NumberS023
Date Received11/02/2018
Decision Date11/30/2018
Product Codes MDS OZO 
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  
New glucose analyzers to be used for in-process testing and lot release activities for the Enlite and Guardian Sensor 3 continuous glucose monitoring sensors. These sensors are components of the MiniMed Paradigm Real-Time Revel, iPro2, 530G, 630G, 670G, and Guardian Connect systems.
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