Device Dossier

Diabetes patient management software

Device Dossier for Diabetes patient management software (Diabetes patient management software, Class IIa, sponsor Medtronic). ARTG record, intended…

Intended purpose

The App is intended to provide a secondary display of insulin pump and CGM data on a supported mobile device. The app also receives and shows alarms, alerts, messages, and reminders from the insulin pump system on a compatible mobile device. The app is not intended to replace the real-time display of insulin pump or CGM data on the primary display device. All therapy decisions should be based on the primary display device. The App is not intended to analyse or modify the insulin pump and CGM data that it receives. Nor is it intended to control any function of the insulin pump or CGM system to which it is connected

TGA Public Summary