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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 #: S053
Dexcom, Inc. Oct 26, 2016 change design/components/specifications/material  
dexcom g4 platinum contiuous glucose monitoring system

supplement #: S055
Dexcom, Inc. Dec 09, 2016 change design/components/specifications/material  
dexcom g4 platinum contiuous glucose monitoring system

supplement #: S056
Dexcom, Inc. Nov 16, 2016 process change - manufacturer/sterilizer/packager/supplier  
dexcom g5 mobile contiuous glucose monitoring system

supplement #: S057
Dexcom, Inc. Jun 06, 2017 change design/components/specifications/material  
dexcom g5 mobile continuous glucose monitoring system

supplement #: S058
Dexcom, Inc. Jan 19, 2017 process change - manufacturer/sterilizer/packager/supplier  
dexcom g4 platinum contiuous glucose monitoring system

supplement #: S059
Dexcom, Inc. May 22, 2017 postapproval study protocol  
dexcom g4 platinum continuous glucose monitoring system; dexcom g5 mobile continuous glucose monitoring system

supplement #: S060
Dexcom, Inc. Nov 03, 2017 process change - manufacturer/sterilizer/packager/supplier  
dexcom g4 platinum contiuous glucose monitoring system, dexcom g5 mobile continuous glucose monitoring system

supplement #: S061
Dexcom, Inc. Apr 26, 2017 process change - manufacturer/sterilizer/packager/supplier  
dexom g4 platinum continuous glucose monitoring system

supplement #: S062
Dexcom, Inc. May 04, 2017 process change - manufacturer/sterilizer/packager/supplier  
dexcom g5 mobile continuous glucose monitoring system

supplement #: S063
Dexcom, Inc. May 10, 2017 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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