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U.S. Department of Health and Human Services

Devices@FDA
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Note: if a medical device has supplements, the device description and instructions may have
changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
 
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36 supplements returned for P150029

New Search  Back to Search Results | Help
Device Name Company Date Approved Supplement Reason Other Information
ipro2 cgm system with enlite sensor

Medtronic Minimed Jun 17, 2016   Approval Order
Summary of Safety & Effectiveness
Labeling
ipro2 cgm system with enlite sensor

supplement #: S001
Medtronic Minimed Aug 15, 2016 process change - manufacturer/sterilizer/packager/supplier  
ipro2 cgm system with enlite sensor

supplement #: S002
Medtronic Minimed Dec 02, 2016 process change - manufacturer/sterilizer/packager/supplier  
ipro2 recorder

supplement #: S003
Medtronic Minimed Dec 19, 2016 process change - manufacturer/sterilizer/packager/supplier  
ipro2 cgm system with enlite sensor

supplement #: S004
Medtronic Minimed Dec 27, 2016 process change - manufacturer/sterilizer/packager/supplier  
ipro2 cgm system with enlite sensor

supplement #: S005
Medtronic Minimed Jan 11, 2017 process change - manufacturer/sterilizer/packager/supplier  
ipro2 cgm system with enlite sensor

supplement #: S006
Medtronic Minimed Mar 27, 2017 labeling change - indications/instructions/shelf life/tradename  
ipro2 cgm system with enlite sensor

supplement #: S008
Medtronic Minimed Apr 27, 2017 process change - manufacturer/sterilizer/packager/supplier  
ipro2 continuous glucose monitoring (cgm) system with enlite system

supplement #: S009
Medtronic Minimed Jun 23, 2017 process change - manufacturer/sterilizer/packager/supplier  
ipro2 professional continuous glucose monitoring (cgm) system

supplement #: S010
Medtronic Minimed Aug 11, 2017 change design/components/specifications/material  
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