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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 NAVIGATOR CONTINUOUS GLUCOSE MONITOR
Generic NameSensor, glucose, invasive
ApplicantAbbott Laboratories
1360 South Loop Road
Alameda, CA 94502
PMA NumberP050020
Date Received06/08/2005
Decision Date03/12/2008
Withdrawal Date 03/18/2013
Product Code MDS 
Docket Number 08M-0207
Notice Date 04/01/2008
Advisory Committee Clinical Chemistry
Expedited Review Granted? Yes
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM. THE DEVICE IS INDICATED FOR THE FOLLOWING: THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM IS INDICATED FOR CONTINUALLY RECORDING INTERSTITIAL FLUID GLUCOSE LEVELS IN PEOPLE (AGES 18 AND OLDER) WITH DIABETES MELLITUS FOR THE PURPOSE OF IMPROVING DIABETES MANAGEMENT. READINGS AND ALARMS ABOUT GLUCOSE LEVELS FROM THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM ARE NOT INTENDED TO REPLACE TRADITIONAL BLOOD GLUCOSE MONITORING. BEFORE ADJUSTING THERAPY FOR DIABETES MANAGEMENT BASED ON THE RESULTS AND ALARMS FROM THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM, TRADITIONAL BLOOD GLUCOSE TESTS MUST BE PERFORMED. THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM PROVIDES A BUILT-IN BLOOD GLUCOSE METER TO CONFIRM THE CONTINUOUS GLUCOSE RESULT. THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM PROVIDES REAL-TIME READINGS, GRAPHS, TRENDS AND GLUCOSE ALARMS DIRECTLY TO THE USER. THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM IS INTENDED TO BE USED IN HOME SETTINGS TO AID PEOPLE WITH DIABETES IN PREDICTING AND DETECTING EPISODES OF HYPOGLYCEMIA AND HYPERGLYCEMIA AND IN CLINICAL SETTINGS TO AID HEALTHCARE PROFESSIONALS IN EVALUATING GLUCOSE CONTROL. THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM IS AVAILABLE ONLY BY PRESCRIPTION.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S015 S017 S018 S019 S020 S021 S022 S024 S026 S027 
S028 S029 S030 S031 S032 S033 S036 
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