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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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61 supplements returned for P150019

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Device Name Company Date Approved Supplement Reason Other Information
paradigm real-time revel system

supplement #: S023
Medtronic Minimed Dec 02, 2016 process change - manufacturer/sterilizer/packager/supplier  
paradigm real-time revel system

supplement #: S024
Medtronic Minimed Jan 25, 2017 change design/components/specifications/material  
minilink real time transmitter

supplement #: S025
Medtronic Minimed Dec 19, 2016 process change - manufacturer/sterilizer/packager/supplier  
paradigm real-time revel system

supplement #: S026
Medtronic Minimed Dec 27, 2016 process change - manufacturer/sterilizer/packager/supplier  
paradigm real-time revel system

supplement #: S027
Medtronic Minimed Mar 27, 2017 labeling change - indications/instructions/shelf life/tradename  
paradigm real-time reveal system

supplement #: S028
Medtronic Minimed Apr 27, 2017 process change - manufacturer/sterilizer/packager/supplier  
paradigm real-time revel insulin pump

supplement #: S029
Medtronic Minimed May 10, 2017 process change - manufacturer/sterilizer/packager/supplier  
paradigm real time revel system

supplement #: S030
Medtronic Minimed Jun 23, 2017 process change - manufacturer/sterilizer/packager/supplier  
paradigm real-time revel system enlite sensor

supplement #: S031
Medtronic Minimed Aug 16, 2017 process change - manufacturer/sterilizer/packager/supplier  
minimed 630g system with enlite sensor

supplement #: S032
Medtronic Minimed Nov 28, 2017 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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