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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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49 supplements returned for P050012

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Device Name Company Date Approved Supplement Reason Other Information
dexcom sts continous monitors

Dexcom, Inc. Mar 24, 2006   Approval Order
Summary of Safety & Effectiveness
Labeling
seven plus continous glucose monitoring system

supplement #: S001
Dexcom, Inc. May 31, 2007 change design/components/specifications/material Approval Order
Summary of Safety & Effectiveness
Labeling
dexcom sts system

supplement #: S002
Dexcom, Inc. Aug 21, 2006 change design/components/specifications/material  
dexcom short term glucose sensor (sts)

supplement #: S003
Dexcom, Inc. Sep 01, 2006 process change - manufacturer/sterilizer/packager/supplier  
dexcom short term glucose sensor (sts)

supplement #: S004
Dexcom, Inc. Sep 22, 2006 process change - manufacturer/sterilizer/packager/supplier  
dexcom sts system

supplement #: S005
Dexcom, Inc. Dec 26, 2006 process change - manufacturer/sterilizer/packager/supplier  
dexcom sts system

supplement #: S006
Dexcom, Inc. Jan 23, 2007 process change - manufacturer/sterilizer/packager/supplier  
dexcom sts system

supplement #: S007
Dexcom, Inc. Feb 26, 2007 process change - manufacturer/sterilizer/packager/supplier  
dexcom sts system

supplement #: S008
Dexcom, Inc. Mar 15, 2007 process change - manufacturer/sterilizer/packager/supplier  
dexcom sts system

supplement #: S009
Dexcom, Inc. Apr 10, 2007 process change - manufacturer/sterilizer/packager/supplier  
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