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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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30 supplements returned for P050020

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Device Name Company Date Approved Supplement Reason Other Information
freestyle navigator continuous glucose monitor

Abbott Laboratories Mar 12, 2008   Approval Order
Summary of Safety & Effectiveness
Labeling
freestyle navigator continuous glucose monitoring system

supplement #: S001
Abbott Laboratories Apr 02, 2008 process change - manufacturer/sterilizer/packager/supplier  
freestyle navigator continuous glucose monitoring system

supplement #: S002
Abbott Laboratories May 15, 2008 change design/components/specifications/material  
freestyle navigator

supplement #: S003
Abbott Laboratories May 21, 2008 labeling change - indications/instructions/shelf life/tradename  
freestyle navigator continuous glucose monitoring system

supplement #: S004
Abbott Laboratories Oct 08, 2008 change design/components/specifications/material  
freestyle navigator continuous glucose monitoring system

supplement #: S005
Abbott Laboratories Jun 02, 2008 process change - manufacturer/sterilizer/packager/supplier  
freestyle navigator continuous glucose monitoring system

supplement #: S006
Abbott Laboratories Aug 06, 2008 process change - manufacturer/sterilizer/packager/supplier  
freestyle navigator continuous glucose monitoring system

supplement #: S007
Abbott Laboratories Aug 25, 2008 process change - manufacturer/sterilizer/packager/supplier  
freestyle navigator contiuous glucose monitoring system

supplement #: S008
Abbott Laboratories Oct 29, 2009 change design/components/specifications/material  
freestyle navigator continuous glucose monitoring system

supplement #: S009
Abbott Laboratories Mar 06, 2009 process change - manufacturer/sterilizer/packager/supplier  
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