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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 g4 platinum contiuous glucose monitoring system

Dexcom, Inc. Oct 05, 2012   Approval Order
Summary of Safety & Effectiveness
Labeling
dexcom g4 platinum professional continuous glucose monitoring system

supplement #: S001
Dexcom, Inc. Jan 04, 2013 process change - manufacturer/sterilizer/packager/supplier  
dexcom g4® platinum (pediatric) continuous glucose monitoring system

supplement #: S002
Dexcom, Inc. Feb 03, 2014 labeling change - indications/instructions/shelf life/tradename Approval Order
Summary of Safety & Effectiveness
Labeling
dexcom g4 plantinum continuous glucose monitoring system

supplement #: S003
Dexcom, Inc. Mar 26, 2013 process change - manufacturer/sterilizer/packager/supplier  
dexcom g4 platinum continuous glucose monitoring system

supplement #: S004
Dexcom, Inc. Apr 11, 2013 process change - manufacturer/sterilizer/packager/supplier  
dexcom g4 platinum continuous glucose monitoring system

supplement #: S005
Dexcom, Inc. Aug 14, 2013 change design/components/specifications/material  
dexcom g4 platinum continuous glucose monitoring system

supplement #: S006
Dexcom, Inc. Jun 28, 2013 process change - manufacturer/sterilizer/packager/supplier  
dexcom g4 platinum continuous glucose monitoring system

supplement #: S007
Dexcom, Inc. Aug 09, 2013 process change - manufacturer/sterilizer/packager/supplier  
dexcom g4 platinum continous glucose monitoring system

supplement #: S008
Dexcom, Inc. Aug 21, 2013 process change - manufacturer/sterilizer/packager/supplier  
dexcom g4 platinum continuous glucose monitoring system

supplement #: S009
Dexcom, Inc. Oct 17, 2014 change design/components/specifications/material  
  We welcome your comments and feedback about Devices@FDA.
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