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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 CGM SYSTEM WITH ENLITE SENSOR
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP150029
Supplement NumberS011
Date Received07/17/2017
Decision Date08/16/2017
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  
Changes to the test method and acceptance criteria for the glucose layer membrane solution release testing that is performed for use of the solution in Enlite Sensor fabrication. The Enlite Sensor is a component of the MiniMed 530G System, MiniMed 630G System, Paradigm Real-Time Revel System, and iPro2 Continuous Glucose Monitoring System.
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