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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 #: S053
Abbott Diabetes Care, Inc. Jun 30, 2023 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre 14 day flash glucose monitoring system

supplement #: S055
Abbott Diabetes Care, Inc. Nov 21, 2023 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre 14 day flash glucose monitoring system

supplement #: S056
Abbott Diabetes Care, Inc. Apr 05, 2024 postapproval study protocol  
freestyle libre 14-day flash glucose monitoring system

supplement #: S057
Abbott Diabetes Care, Inc. Jul 11, 2025 process change - manufacturer/sterilizer/packager/supplier  
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