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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 PRO FLASH GLUCOSE MONITORING SYSTEM
Generic NameSensor, glucose, invasive
ApplicantAbbott Diabetes Care Inc.
1360 SOUTH LOOP RD.
ALAMEDA, CA 94502
PMA NumberP150021
Date Received06/19/2015
Decision Date09/23/2016
Product Code MDS 
Docket Number 16M-2971
Notice Date 09/26/2016
Advisory Committee Clinical Chemistry
Clinical TrialsNCT02073058
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The FreeStyle Libre Pro Flash Glucose Monitoring System is a professional continuous glucose monitoring (CGM) device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes. The System is intended for use by health care professionals and requires a prescription. Readings from the FreeStyle Libre Pro Sensor are only made available to patients through consultation with a health care professional. The System does not require user calibration with blood glucose values.The FreeStyle Libre Pro System aids in the detection of glucose level excursions above or below the desired range, facilitating therapy adjustments. Interpretation of the FreeStyle Libre Pro Flash Glucose Monitoring System readings should be based on the trends and patterns analyzed through time using the reports available.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements: S021 S022 S023 S024 S025 S026 S055 S056 S012 S007 S008 S009 
S010 S001  S051 S052 S003 S004 S005 S006 S032 S033 S034 
S050 S049 S046 S038 S039 S040 S029 S030 S011 S018 S019 S027 
S028 S013 S014 S015 S016 S017 S035 S031 S043 S044 S047 S045 
S036 S037 S042 S048 S041 S053 S057 S054 S059 S058 
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