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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

New Search  Back to Search Results | Help
Device Name Company Date Approved Supplement Reason Other Information
g5 mobile continuous glucose monitoring systems

supplement #: S076
Dexcom, Inc. Jun 22, 2018 process change - manufacturer/sterilizer/packager/supplier  
g5 mobile continuous glucose monitoring system

supplement #: S077
Dexcom, Inc. Oct 11, 2018 process change - manufacturer/sterilizer/packager/supplier  
g4 platinum continuous glucose monitoring system and g5 mobile continuous glucose monitoring system

supplement #: S078
Dexcom, Inc. Oct 04, 2018 process change - manufacturer/sterilizer/packager/supplier  
dexcom g5 platinum contiuous glucose monitoring system

supplement #: S079
Dexcom, Inc. Dec 04, 2018 process change - manufacturer/sterilizer/packager/supplier  
dexcom g5 mobile continuous glucose monitoring system

supplement #: S080
Dexcom, Inc. Mar 15, 2019 postapproval study protocol  
dexcom g5 mobile continuous glucose monitoring system

supplement #: S081
Dexcom, Inc. Apr 24, 2019 change design/components/specifications/material  
dexcom g4 platinum continuous glucose monitoring system, dexcom g5 mobile continuous glucose monitoring system

supplement #: S082
Dexcom, Inc. Aug 20, 2019 change design/components/specifications/material  
dexcom g5 mobile continuous glucose monitoring system

supplement #: S083
Dexcom, Inc. Nov 01, 2019 postapproval study protocol  
dexcom g5 mobile continuous glucose monitoring system

supplement #: S086
Dexcom, Inc. Jan 08, 2020 process change - manufacturer/sterilizer/packager/supplier  
g5 mobile continuous glucose monitoring system

supplement #: S087
Dexcom, Inc. Sep 03, 2020 postapproval study protocol  
  We welcome your comments and feedback about Devices@FDA.
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