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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.
 
DeviceMedtronic MiniMed iPro2 CGM System with Enlite Sensor
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP150029
Supplement NumberS014
Date Received12/22/2017
Decision Date01/19/2018
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
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Adding a new ISO Class 8 Cleanroom for the manufacturing of Enlite Sensors and Guardian Sensors at Medtronics Northridge facility. The Enlite sensors are components of the MiniMed 530G, Paradigm Real-Time Revel, and iPro2 CGM systems and the Guardian Sensors are components of the MiniMed 630G and MiniMed 670G systems.
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