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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
dexcom g4 platinum continuous glucose monitoring system,dexcom g5 mobile continuous glucose monitoring system

supplement #: S042
Dexcom, Inc. Feb 05, 2016 change design/components/specifications/material  
dexcom g4tm platinum continuous glucose monitoring system, dexcom g5 mobile continious glucose monitoring system

supplement #: S043
Dexcom, Inc. Jan 14, 2016 process change - manufacturer/sterilizer/packager/supplier  
dexcom g4 platinum continuous monitoring system, dexcom g5 mobile continuous glucose monitoring system

supplement #: S044
Dexcom, Inc. Jan 13, 2016 process change - manufacturer/sterilizer/packager/supplier  
dexcom g4 platinum contiuous glucose monitoring system

supplement #: S046
Dexcom, Inc. Apr 21, 2016 process change - manufacturer/sterilizer/packager/supplier  
dexcom g4 platinum receiver, g4 platinum pediatric receiver, dexcom g5 mobile receiver, dexcom g4 platinum receiver wit

supplement #: S047
Dexcom, Inc. Jul 08, 2016 change design/components/specifications/material  
dexcom g5 mobile continuous glucose monitoring system

supplement #: S048
Dexcom, Inc. Aug 02, 2016 change design/components/specifications/material  
dexcom g5 mobile contiuous glucose monitoring system

supplement #: S049
Dexcom, Inc. Sep 16, 2016 change design/components/specifications/material  
dexcom g5 mobile continuous glucose monitoring system

supplement #: S050
Dexcom, Inc. Mar 08, 2017 change design/components/specifications/material  
g4 platinum continuous glucose monitoring system/dexcom g5 mobile continuous glucose monitoring system

supplement #: S051
Dexcom, Inc. Aug 12, 2016 process change - manufacturer/sterilizer/packager/supplier  
g4 platinum contiuous glucose monitoring system

supplement #: S052
Dexcom, Inc. Aug 25, 2016 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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