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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 #: S042
Medtronic, Inc. Jan 29, 2015 change design/components/specifications/material  
minimed 530g insulin pumps

supplement #: S043
Medtronic, Inc. Dec 03, 2014 process change - manufacturer/sterilizer/packager/supplier  
artificial pancreas device system

supplement #: S045
Medtronic, Inc. Dec 04, 2014 process change - manufacturer/sterilizer/packager/supplier  
minimed 530g insulin pump

supplement #: S046
Medtronic, Inc. Oct 02, 2015 labeling change - indications/instructions/shelf life/tradename Approval Order
Summary of Safety & Effectiveness
Labeling
minimed 530g system

supplement #: S047
Medtronic, Inc. Dec 19, 2014 process change - manufacturer/sterilizer/packager/supplier  
enlite glucose sensors

supplement #: S048
Medtronic, Inc. Dec 31, 2014 process change - manufacturer/sterilizer/packager/supplier  
minimed 530g system and minilink real-time system

supplement #: S049
Medtronic, Inc. Jan 02, 2015 process change - manufacturer/sterilizer/packager/supplier  
enlite glucose sensors

supplement #: S050
Medtronic, Inc. Jan 07, 2015 process change - manufacturer/sterilizer/packager/supplier  
mini-med 530g insulin pump

supplement #: S051
Medtronic, Inc. Jan 14, 2015 process change - manufacturer/sterilizer/packager/supplier  
minimed 530g insulin pump

supplement #: S052
Medtronic, Inc. Aug 25, 2015 change design/components/specifications/material  
  We welcome your comments and feedback about Devices@FDA.
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