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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 14day flash glucose monitoring system

supplement #: S032
Abbott Diabetes Care, Inc. Mar 04, 2019 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre flash glucose monitoring system; freestyle libre 14 day flash glucose monitoring system

supplement #: S033
Abbott Diabetes Care, Inc. May 10, 2019 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre 14 day flash glucose monitoring system

supplement #: S035
Abbott Diabetes Care, Inc. Jun 20, 2019 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre 14 day flash glucose monitoring system

supplement #: S036
Abbott Diabetes Care, Inc. Aug 13, 2019 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre 14 day flash glucose monitoring system

supplement #: S037
Abbott Diabetes Care, Inc. Aug 15, 2019 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre pro flash glucose monitoring system

supplement #: S038
Abbott Diabetes Care, Inc. Sep 12, 2019 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre 14 day flash glucose monitoring system

supplement #: S039
Abbott Diabetes Care, Inc. May 12, 2020 change design/components/specifications/material  
freestyle libre 14-day flash glucose monitoring system

supplement #: S040
Abbott Diabetes Care, Inc. Dec 16, 2019 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre 14-day flash glucose monitoring system

supplement #: S041
Abbott Diabetes Care, Inc. Apr 13, 2020 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre 14 day flash glucose monitoring system

supplement #: S042
Abbott Diabetes Care, Inc. May 21, 2020 location change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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