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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 system

supplement #: S032
Medtronic, Inc. Sep 29, 2014 postapproval study protocol - osb  
minimed 530g insulin pump

supplement #: S033
Medtronic, Inc. Oct 08, 2014 process change - manufacturer/sterilizer/packager/supplier  
enlite glucose sensors

supplement #: S034
Medtronic, Inc. Oct 02, 2014 process change - manufacturer/sterilizer/packager/supplier  
enlite glucose sensors

supplement #: S035
Medtronic, Inc. Oct 02, 2014 process change - manufacturer/sterilizer/packager/supplier  
minimed 530g insulin pump

supplement #: S036
Medtronic, Inc. Feb 13, 2015 change design/components/specifications/material  
minimed 530g insulin pump

supplement #: S037
Medtronic, Inc. Nov 19, 2014 process change - manufacturer/sterilizer/packager/supplier  
enlite sensor

supplement #: S038
Medtronic, Inc. Nov 21, 2014 process change - manufacturer/sterilizer/packager/supplier  
minimed 530g insulin pump

supplement #: S039
Medtronic, Inc. Nov 26, 2014 process change - manufacturer/sterilizer/packager/supplier  
enlite sensor

supplement #: S040
Medtronic, Inc. May 13, 2015 process change - manufacturer/sterilizer/packager/supplier  
enlite glucose sensors

supplement #: S041
Medtronic, Inc. Jan 28, 2015 change design/components/specifications/material  
  We welcome your comments and feedback about Devices@FDA.
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