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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 continuous glucose monitoring system

supplement #: S010
Dexcom, Inc. Aug 19, 2013 process change - manufacturer/sterilizer/packager/supplier  
dexcom g4 platinum professional continuous glucose monitoring system

supplement #: S011
Dexcom, Inc. Jun 03, 2014 labeling change - indications/instructions/shelf life/tradename  
dexcom g4 platinum continuous glucose monitoring system

supplement #: S012
Dexcom, Inc. Oct 18, 2013 process change - manufacturer/sterilizer/packager/supplier  
dexcom g4 platinum continous glucose monitoring system

supplement #: S013
Dexcom, Inc. Feb 26, 2014 change design/components/specifications/material  
dexcom g4 platinum continuous glucose monitoring system

supplement #: S014
Dexcom, Inc. Mar 05, 2014 change design/components/specifications/material  
dexcon g4 platinum continuous glucose monitoring system

supplement #: S017
Dexcom, Inc. May 02, 2014 process change - manufacturer/sterilizer/packager/supplier  
dexcom g4 platinum continuous glucose monitioring system

supplement #: S018
Dexcom, Inc. Oct 21, 2014 change design/components/specifications/material Approval Order
Summary of Safety & Effectiveness
Labeling
dexcom g4 platinum continuous glucose monitoring system

supplement #: S019
Dexcom, Inc. Jul 11, 2014 change design/components/specifications/material  
dexcom g4 platinum continuous glucose monitoring system

supplement #: S020
Dexcom, Inc. Jun 18, 2014 process change - manufacturer/sterilizer/packager/supplier  
dexcom g4 platinum continuous glucose monitoring system

supplement #: S021
Dexcom, Inc. Jun 30, 2014 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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