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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 #: S011
Abbott Diabetes Care, Inc. Mar 29, 2018 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre flash glucose monitoring system

supplement #: S012
Abbott Diabetes Care, Inc. Mar 27, 2018 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre flash glucose monitoring system

supplement #: S013
Abbott Diabetes Care, Inc. Apr 05, 2018 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre flash glucose monitoring system

supplement #: S014
Abbott Diabetes Care, Inc. Jul 23, 2018 change design/components/specifications/material  
freestyle libre flash glucose monitoring system

supplement #: S015
Abbott Diabetes Care, Inc. Apr 17, 2018 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre flash glucose monitoring system

supplement #: S016
Abbott Diabetes Care, Inc. Apr 25, 2018 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre 14 day flash glucose monitoring system

supplement #: S017
Abbott Diabetes Care, Inc. Jul 23, 2018 labeling change - indications/instructions/shelf life/tradename Approval Order
Summary of Safety & Effectiveness
Labeling
freestyle libre flash glucose monitoring system

supplement #: S018
Abbott Diabetes Care, Inc. Jul 27, 2018 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre flash glucose monitoring system

supplement #: S019
Abbott Diabetes Care, Inc. Jun 01, 2018 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre flash glucose monitoring system

supplement #: S020
Abbott Diabetes Care, Inc. Jun 28, 2018 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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