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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
minimed paradigm real-time revel system

supplement #: S033
Medtronic Minimed Dec 21, 2017 process change - manufacturer/sterilizer/packager/supplier  
paradigm real-time revel system

supplement #: S034
Medtronic Minimed Feb 14, 2018 change design/components/specifications/material  
medtronic minimed paradigm real-time revel system

supplement #: S035
Medtronic Minimed Jan 19, 2018 process change - manufacturer/sterilizer/packager/supplier  
paradigm real time revel insulin pump

supplement #: S036
Medtronic Minimed Feb 28, 2018 process change - manufacturer/sterilizer/packager/supplier  
paradigm real time revel insulin pump

supplement #: S037
Medtronic Minimed Feb 28, 2018 process change - manufacturer/sterilizer/packager/supplier  
revel system with enlite system

supplement #: S038
Medtronic Minimed Mar 09, 2018 process change - manufacturer/sterilizer/packager/supplier  
paradigm real-time revel system

supplement #: S039
Medtronic Minimed Mar 07, 2018 change design/components/specifications/material  
paradigm real-time revel system

supplement #: S040
Medtronic Minimed Apr 10, 2018 process change - manufacturer/sterilizer/packager/supplier  
medtronic minimed paradigm real-time revel system

supplement #: S041
Medtronic Minimed May 23, 2018 process change - manufacturer/sterilizer/packager/supplier  
paradigm real-time revel insulin pump

supplement #: S042
Medtronic Minimed May 30, 2018 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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