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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
Generic NameSensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
ApplicantAbbott Diabetes Care, Inc.
1360 S. Loop Dr.
Alameda, CA 94502
PMA NumberP160030
Supplement NumberS030
Date Received01/15/2019
Decision Date10/07/2019
Product Code PZE 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT02082184
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for an alternate supplier for the PCB of the reader component of the FreeStyle Libre, FreeStyle Libre 14-day, and FreeStyle Libre Pro Flash Continuous Glucose Monitoring Systems.
Post-Approval StudyShow Report Schedule and Study Progress
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