Freestyle Navigator Continuous Glucose Monitor

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.