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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 14-day flash glucose monitoring system

supplement #: S043
Abbott Diabetes Care, Inc. Jul 30, 2020 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre 14-day flash glucose monitoring system

supplement #: S044
Abbott Diabetes Care, Inc. Nov 19, 2021 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre 14-day flash glucose monitoring system

supplement #: S045
Abbott Diabetes Care, Inc. Dec 16, 2020 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre 14-day flash glucose monitoring system

supplement #: S046
Abbott Diabetes Care, Inc. Jan 05, 2021 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre 14-day flash glucose monitoring system

supplement #: S047
Abbott Diabetes Care, Inc. Sep 01, 2021 change design/components/specifications/material  
freestyle libre 14 day flash glucose monitoring system

supplement #: S048
Abbott Diabetes Care, Inc. Jan 19, 2022 postapproval study protocol  
freestyle libre 14-day flash glucose monitoring system

supplement #: S049
Abbott Diabetes Care, Inc. Mar 02, 2022 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre 14-day flash glucose monitoring system

supplement #: S050
Abbott Diabetes Care, Inc. Mar 16, 2022 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre 14 day flash glucose monitoring system

supplement #: S051
Abbott Diabetes Care, Inc. Apr 28, 2022 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre 14-day flash glucose monitoring system

supplement #: S052
Abbott Diabetes Care, Inc. Jan 17, 2023 postapproval study protocol  
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