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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
Classification Namesensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
Generic Namesensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
Applicant
ABBOTT DIABETES CARE INC.
1360 south loop dr.
alameda, CA 94502-7000
PMA NumberP160030
Date Received08/01/2016
Decision Date09/27/2017
Product Code
PZE[ Registered Establishments with PZE ]
Docket Number 17M-5969
Notice Date 09/29/2017
Advisory Committee Clinical Chemistry
Clinical Trials NCT02082184
NCT02232698
NCT02283411
NCT02388815
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S002 
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