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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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53 supplements returned for P160030

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Device Name Company Date Approved Supplement Reason Other Information
freestyle libre flash glucose monitoring system

Abbott Diabetes Care, Inc. Sep 27, 2017   Approval Order
Summary of Safety & Effectiveness
Labeling
freestyle libre flash glucose monitoring system

supplement #: S001
Abbott Diabetes Care, Inc. Dec 08, 2017 postapproval study protocol  
freestyle libre flash glucose monitoring system

supplement #: S002
Abbott Diabetes Care, Inc. Nov 28, 2017 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre flash glucose monitoring system

supplement #: S003
Abbott Diabetes Care, Inc. Dec 20, 2017 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre flash glucose monitoring system

supplement #: S004
Abbott Diabetes Care, Inc. Dec 21, 2017 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre flash glucose monitoring system

supplement #: S005
Abbott Diabetes Care, Inc. Dec 22, 2017 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre flash glucose monitoring system

supplement #: S006
Abbott Diabetes Care, Inc. Dec 28, 2017 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre flash glucose monitoring system

supplement #: S007
Abbott Diabetes Care, Inc. Feb 26, 2018 change design/components/specifications/material  
freestyle libre flash glucose monitoring system

supplement #: S008
Abbott Diabetes Care, Inc. Dec 29, 2017 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre flash glucose monitoring system; freestyle libre 14 day flash glucose monitoring system

supplement #: S010
Abbott Diabetes Care, Inc. Oct 31, 2018 change design/components/specifications/material  
  We welcome your comments and feedback about Devices@FDA.
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