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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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134 supplements returned for P120010

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Device Name Company Date Approved Supplement Reason Other Information
enlite sensor

supplement #: S073
Medtronic, Inc. Nov 18, 2015 process change - manufacturer/sterilizer/packager/supplier  
minimed 530g insulin pump

supplement #: S074
Medtronic, Inc. Feb 01, 2016 change design/components/specifications/material  
minimed 530g insulin pump

supplement #: S075
Medtronic, Inc. Dec 03, 2015 process change - manufacturer/sterilizer/packager/supplier  
minimed 530g insulin pump

supplement #: S076
Medtronic, Inc. Jun 03, 2016 process change - manufacturer/sterilizer/packager/supplier  
minimed 530g system

supplement #: S077
Medtronic, Inc. Dec 09, 2015 process change - manufacturer/sterilizer/packager/supplier  
minimed 530g insulin pump

supplement #: S078
Medtronic, Inc. Dec 08, 2015 process change - manufacturer/sterilizer/packager/supplier  
minimed 530g

supplement #: S079
Medtronic, Inc. Dec 09, 2015 process change - manufacturer/sterilizer/packager/supplier  
minimed 530g system

supplement #: S080
Medtronic, Inc. Dec 23, 2015 process change - manufacturer/sterilizer/packager/supplier  
enlite glucose sensor

supplement #: S081
Medtronic, Inc. Jan 14, 2016 process change - manufacturer/sterilizer/packager/supplier  
artificial pancreas device system, threshold suspend

supplement #: S082
Medtronic, Inc. Jan 27, 2016 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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