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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

supplement #: S032
Medtronic Minimed Nov 22, 2019 process change - manufacturer/sterilizer/packager/supplier  
ipro2 cgm system

supplement #: S033
Medtronic Minimed Nov 15, 2019 process change - manufacturer/sterilizer/packager/supplier  
ipro2 cgm system with enlite sensor

supplement #: S034
Medtronic Minimed Dec 19, 2019 process change - manufacturer/sterilizer/packager/supplier  
ipro2 cgm system with enlite sensor

supplement #: S035
Medtronic Minimed Dec 01, 2020 process change - manufacturer/sterilizer/packager/supplier  
ipro2 cgm system with enlite glucose sensor

supplement #: S036
Medtronic Minimed Feb 25, 2021 labeling change - indications/instructions/shelf life/tradename  
ipro™ 2 cgm system with enlite™ glucose sensor

supplement #: S037
Medtronic Minimed Dec 17, 2021 labeling change - indications/instructions/shelf life/tradename  
enlite sensor (mmt-7008)

supplement #: S038
Medtronic Minimed Apr 29, 2022 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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