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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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99 supplements returned for P150001

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Device Name Company Date Approved Supplement Reason Other Information
minimed 630g system with smartguard

supplement #: S022
Medtronic Minimed Oct 31, 2017 change design/components/specifications/material  
medtronic minimed 630g insulin pump

supplement #: S023
Medtronic Minimed Oct 11, 2017 process change - manufacturer/sterilizer/packager/supplier  
guardian sensor (3)

supplement #: S024
Medtronic Minimed Oct 23, 2017 process change - manufacturer/sterilizer/packager/supplier  
minimed 630g pump

supplement #: S025
Medtronic Minimed Oct 26, 2017 process change - manufacturer/sterilizer/packager/supplier  
minimed 630g system with smartguard

supplement #: S026
Medtronic Minimed Nov 07, 2017 process change - manufacturer/sterilizer/packager/supplier  
paradigm real-time revel system

supplement #: S027
Medtronic Minimed Nov 28, 2017 process change - manufacturer/sterilizer/packager/supplier  
minimed 630g insulin pump

supplement #: S028
Medtronic Minimed Dec 20, 2017 change design/components/specifications/material  
minimed 630g system

supplement #: S030
Medtronic Minimed Dec 21, 2017 process change - manufacturer/sterilizer/packager/supplier  
minimed 630g system

supplement #: S031
Medtronic Minimed Feb 14, 2018 change design/components/specifications/material  
medtronic minimed 630g system

supplement #: S032
Medtronic Minimed Jan 19, 2018 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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