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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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83 supplements returned for P120005

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Device Name Company Date Approved Supplement Reason Other Information
dexcom g5 mobile continuous glucose monitoring system

supplement #: S064
Dexcom, Inc. Aug 11, 2017 change design/components/specifications/material  
dexcon g5 mobile continuous glucose monitoring system

supplement #: S065
Dexcom, Inc. Sep 21, 2017 change design/components/specifications/material  
dexcom g5 mobile continuous glucose monitoring system

supplement #: S066
Dexcom, Inc. Sep 09, 2017 process change - manufacturer/sterilizer/packager/supplier  
dexcom g4 platinum continuous glucose monitoring system and dexcom 5 mobile continuous glucose monitoring system

supplement #: S067
Dexcom, Inc. May 07, 2018 location change - manufacturer/sterilizer/packager/supplier  
dexcom g5 mobile continuous glucose monitoring system

supplement #: S068
Dexcom, Inc. Nov 14, 2017 process change - manufacturer/sterilizer/packager/supplier  
dexcon g4 platinum and g5 mobile continuous glucose monitoring system

supplement #: S069
Dexcom, Inc. Jan 10, 2018 process change - manufacturer/sterilizer/packager/supplier  
dexcom g4 platinum and g5 mobile continuous glucose monitoring systems

supplement #: S071
Dexcom, Inc. Mar 27, 2018 process change - manufacturer/sterilizer/packager/supplier  
g5 mobile transmitter hardware and firmware, g5 mobile continuous glucose monitoring system

supplement #: S073
Dexcom, Inc. Jul 03, 2018 change design/components/specifications/material  
dexcom g5 mobile continuous glucose monitoring system

supplement #: S074
Dexcom, Inc. Jun 13, 2018 process change - manufacturer/sterilizer/packager/supplier  
dexcom g4 platinum/g5 mobile continuous glucose monitoring system

supplement #: S075
Dexcom, Inc. Jun 15, 2018 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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