The Guardian™ 4 sensor has been studied and is approved for use in patients ages 7 years and older and in the arm insertion site only. All therapy adjustments in manual mode should be based on measurements obtained using a blood glucose meter and not on values provided by the Guardian™ 4 sensor. The Guardian™ 4 sensor is not intended to be used directly to make therapy adjustments while the MiniMed™ 780G is operating in manual mode. The Guardian™ (4) sensor is indicated for up to seven days of continuous use.

The sensor is intended for single use and requires a prescription. The Guardian™ 4 Sensor is intended for use with the MiniMed™ 780G system and the Guardian 4 transmitter to monitor glucose levels for the management of diabetes. The system requires a prescription from a healthcare professional.

The Medtronic MiniMed™ 780G System consists of the following devices: MiniMed™ 780G Insulin Pump, the Guardian™ 4 Transmitter, the Guardian™ 4 Sensor, One-press serter, the Accu-Chek™ Guide Link blood glucose meter, and the Accu-Chek™ Guide Test Strips. The MiniMed™ 780GSystem includes SmartGuard™ technology, which can be programmed to automatically adjust insulin delivery based on the continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values. The MiniMed™ 780G system is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the management of type 1 diabetes mellitus in persons seven years of age and older requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. Important Safety Information: MiniMed™ 780G system with SmartGuard™ Technology with Guardian™ 4 sensor

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