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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

New Search  Back to Search Results | Help
Device Name Company Date Approved Supplement Reason Other Information
freestyle libre pro flash glucose monitoring system

Abbott Diabetes Care, Inc. Sep 23, 2016   Approval Order
Summary of Safety & Effectiveness
Labeling
freestyle libre pro flash glucose monitoring system

supplement #: S001
Abbott Diabetes Care, Inc. Jun 02, 2017 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre pro flash glucose monitoring system

supplement #: S003
Abbott Diabetes Care, Inc. Jan 12, 2017 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre pro flash glucose monitoring system

supplement #: S004
Abbott Diabetes Care, Inc. May 31, 2017 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre pro flash glucose monitoring system

supplement #: S005
Abbott Diabetes Care, Inc. Apr 26, 2017 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre pro flash glucose monitoring system

supplement #: S006
Abbott Diabetes Care, Inc. Jun 23, 2017 change design/components/specifications/material  
freestyle libre pro flash glucose monitoring system

supplement #: S007
Abbott Diabetes Care, Inc. Jul 28, 2017 change design/components/specifications/material  
freestyle libre pro flash glucose monitoring system

supplement #: S008
Abbott Diabetes Care, Inc. Nov 16, 2017 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre pro flash glucose monitoring system

supplement #: S009
Abbott Diabetes Care, Inc. Jun 12, 2018 process change - manufacturer/sterilizer/packager/supplier  
freestyle libre pro flash glucose monitoring system

supplement #: S010
Abbott Diabetes Care, Inc. Jul 12, 2017 process change - manufacturer/sterilizer/packager/supplier  
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