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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 #: S010
Medtronic Minimed Apr 07, 2016 process change - manufacturer/sterilizer/packager/supplier  
paradigm real-time revel system

supplement #: S011
Medtronic Minimed Apr 21, 2016 process change - manufacturer/sterilizer/packager/supplier  
paradigm real-time revel system

supplement #: S012
Medtronic Minimed Apr 21, 2016 process change - manufacturer/sterilizer/packager/supplier  
paradigm real-time revel system

supplement #: S013
Medtronic Minimed Apr 27, 2016 process change - manufacturer/sterilizer/packager/supplier  
paradigm real-time revel system with enlite sensor

supplement #: S014
Medtronic Minimed Dec 21, 2018 process change - manufacturer/sterilizer/packager/supplier  
sensor-enabled pump system-continuous glucose monitoring system

supplement #: S016
Medtronic Minimed Dec 08, 2016 process change - manufacturer/sterilizer/packager/supplier  
paradigm real-time revel system

supplement #: S017
Medtronic Minimed Aug 15, 2016 process change - manufacturer/sterilizer/packager/supplier  
paradigm real-time revel insulin system

supplement #: S018
Medtronic Minimed Aug 25, 2016 process change - manufacturer/sterilizer/packager/supplier  
paradigm real-time insulin pump

supplement #: S020
Medtronic Minimed Oct 19, 2016 process change - manufacturer/sterilizer/packager/supplier  
paradigm real-time revel insulin pump with enlite sensor system

supplement #: S022
Medtronic Minimed Oct 13, 2016 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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