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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceFreestyle Libre Flash Glucose Monitoring System
Generic NameSensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
ApplicantABBOTT DIABETES CARE INC.
1360 SOUTH LOOP DR.
ALAMEDA, CA 94502-7000
PMA NumberP160030
Date Received08/01/2016
Decision Date09/27/2017
Product Code PZE 
Docket Number 17M-5969
Notice Date 09/29/2017
Advisory Committee Clinical Chemistry
Clinical TrialsNCT02082184
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the Freestyle Libre Flash Glucose Monitoring System. The FreeStyle Libre Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device indicated for the management of diabetes in persons age 18 and older. It is designed to replace blood glucose testing for diabetes treatment decisions.The System detects trends and tracks patterns aiding in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is intended for single patient use and requires a prescription.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S010 S011 S012 
S013 S014 S015 S016 S017 S018 S019 S020 S022 S023 S024 S025 
S026 S027 S028 S029 S030 S031 S032 S033 S035 S036 S037 S038 
S039 S040 S041 S042 S043 S044 S045 S046 S047 S048 S049 S050 
S051 S052 S053 S055 S056 
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