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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 14 Day Flash Glucose Monitoring System
Generic NameSensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
ALAMEDA, CA 94502-7000
PMA NumberP160030
Supplement NumberS017
Date Received04/10/2018
Decision Date07/23/2018
Product Code PZE 
Docket Number 18M-2886
Notice Date 07/26/2018
Advisory Committee Clinical Chemistry
Clinical TrialsNCT03257501
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the FreeStyle Libre 14 Day Flash Glucose Monitoring System. The FreeStyle Libre 14 Day 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