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U.S. Department of Health and Human Services

Devices@FDA
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceFreestyle Libre Flash Glucose Monitoring System; FreeStyle Libre 14 Day Flash Glucose Monitoring System
Generic NameSensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
ApplicantAbbott Diabetes Care, Inc.
1360 S. Loop Dr.
Alameda, CA 94502
PMA NumberP160030
Supplement NumberS010
Date Received02/26/2018
Decision Date10/31/2018
Product Code PZE 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT02082184
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the addition of the FreeStyle LibreLink App (iOS) as a compatible reading device and alternative primary display for the FreeStyle Libre and Freestyle Libre 14 Day Systems.
Post-Approval StudyShow Report Schedule and Study Progress
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