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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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58 supplements returned for P150021

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Device Name Company Date Approved Supplement Reason Other Information
freestyle libre pro flash glucose monitoring system

supplement #: S011
Abbott Diabetes Care, Inc. Aug 21, 2017 labeling change - indications/instructions/shelf life/tradename  
freestyle libre pro flash glucose monitoring system

supplement #: S012
Abbott Diabetes Care, Inc. Mar 20, 2018 location change - manufacturer/sterilizer/packager/supplier  
freestyle libre pro flash glucose monitoring system

supplement #: S013
Abbott Diabetes Care, Inc. Dec 20, 2017 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre pro flash glucose monitoring system

supplement #: S014
Abbott Diabetes Care, Inc. Dec 21, 2017 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre pro flash glucose monitoring system

supplement #: S015
Abbott Diabetes Care, Inc. Dec 22, 2017 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre pro flash glucose monitoring system

supplement #: S016
Abbott Diabetes Care, Inc. Feb 26, 2018 change design/components/specifications/material  
freestyle libre pro flash glucose monitoring system

supplement #: S017
Abbott Diabetes Care, Inc. Dec 29, 2017 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre pro flash glucose monitoring system

supplement #: S018
Abbott Diabetes Care, Inc. Feb 15, 2018 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre pro flash glucose monitoring system

supplement #: S019
Abbott Diabetes Care, Inc. Feb 22, 2018 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre pro flassh glucose monitoring system

supplement #: S021
Abbott Diabetes Care, Inc. Mar 29, 2018 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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