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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

supplement #: S022
Abbott Diabetes Care, Inc. Jul 06, 2018 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre flash glucose monitoring system

supplement #: S023
Abbott Diabetes Care, Inc. Jul 03, 2018 change design/components/specifications/material  
freestyle libre flash glucose monitoring system

supplement #: S024
Abbott Diabetes Care, Inc. Aug 22, 2018 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre 14 day flash glucose monitoring system

supplement #: S025
Abbott Diabetes Care, Inc. Sep 25, 2018 postapproval study protocol  
freestyle libre flash glucose monitoring system

supplement #: S026
Abbott Diabetes Care, Inc. Sep 19, 2018 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre pro

supplement #: S027
Abbott Diabetes Care, Inc. Dec 21, 2018 change design/components/specifications/material  
freestyle libre pro

supplement #: S028
Abbott Diabetes Care, Inc. Apr 05, 2019 change design/components/specifications/material  
freestyle libre flash glucose monitoring system

supplement #: S029
Abbott Diabetes Care, Inc. Feb 26, 2019 change design/components/specifications/material  
freestyle libre flash glucose monitoring system

supplement #: S030
Abbott Diabetes Care, Inc. Oct 07, 2019 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre flash glucose monitoring system

supplement #: S031
Abbott Diabetes Care, Inc. May 06, 2019 labeling change - indications/instructions/shelf life/tradename  
  We welcome your comments and feedback about Devices@FDA.
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