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U.S. Department of Health and Human Services

Devices@FDA
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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.
 
DeviceiPro2 Continuous Glucose Monitoring (CGM) System with Enlite Sensor
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP150029
Supplement NumberS012
Date Received10/30/2017
Decision Date11/28/2017
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
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Addition of new equipment for the Enlite Sensor substrate manufacturing process. The Enlite Sensor is a component of the following systems: MiniMed 530G System, Paradigm Real-Time Revel System, MiniMed 630G System, iPro2 CGM System with Enlite Sensor.
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