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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
minimed 530g insulin pump

supplement #: S095
Medtronic, Inc. Oct 19, 2016 process change - manufacturer/sterilizer/packager/supplier  
minimed 530g system

supplement #: S097
Medtronic, Inc. Dec 02, 2016 process change - manufacturer/sterilizer/packager/supplier  
minimed 530g system

supplement #: S098
Medtronic, Inc. Dec 19, 2016 process change - manufacturer/sterilizer/packager/supplier  
minimed 530g system

supplement #: S099
Medtronic, Inc. Dec 27, 2016 process change - manufacturer/sterilizer/packager/supplier  
minimed 530g system

supplement #: S100
Medtronic, Inc. Mar 27, 2017 labeling change - indications/instructions/shelf life/tradename  
minimed 530g system

supplement #: S101
Medtronic, Inc. Oct 11, 2017 postapproval study protocol - osb  
artificial pancreas device system threshold suspend

supplement #: S102
Medtronic, Inc. Apr 27, 2017 process change - manufacturer/sterilizer/packager/supplier  
minimed 530g insulin pump

supplement #: S103
Medtronic, Inc. May 10, 2017 process change - manufacturer/sterilizer/packager/supplier  
minimed 530g system

supplement #: S104
Medtronic, Inc. Jun 23, 2017 process change - manufacturer/sterilizer/packager/supplier  
minimed 530g system enlite sensor

supplement #: S105
Medtronic, Inc. Aug 16, 2017 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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