12 | SEVEN
™
CONTINUOUS GLUCOSE MONITORING SYSTEM
INDICATION FOR USE
e SEVEN Continuous Glucose Monitoring System is a glucose-monitoring device
indicated for detecting trends and tracking patterns in adults (age 18 and older) with
diabetes. e SEVEN System is intended for use by patients at home and in health care
facilities. e device is for prescription use only.
e SEVEN Continuous Glucose Monitoring System is indicated for use as an adjunctive
device to complement, not replace, information obtained from standard home glucose
monitoring devices.
e SEVEN Continuous Glucose Monitoring System aids in the detection of episodes
of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy
adjustments, which may minimize these excursions. Interpretation of the SEVEN System
results should be based on the trends and patterns seen with several sequential readings
over time.
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