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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 NumberS002
Date Received11/02/2016
Decision Date12/02/2016
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  
Move a mold to a different press and to change process parameters in the Enlite Sensor and Guardian Sensor manufacturing process. The Enlite Sensor is a component of the MiniMed-530G System, the Minimed Revel Insulin Pump System, the iPro2 CGM System, and the MiniMed 630G System. The Guardian sensor (3) is a component of the MiniMed 670G System.
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