Device Dossier

CardioMessenger Smart 4G - Cardiac pulse generator reader, home-use

Device Dossier for CardioMessenger Smart 4G - Cardiac pulse generator reader, home-use (Cardiac pulse generator reader, home-use, Class III, sponsor…

Intended purpose

Used to automatically and continuously transmit data from a BIOTRONIK cardiac implantable electronic device to a service centre. Home Monitoring is not an emergency system.

Functional description

It collects encoded data from a CIED and transmits it wirelessly to a service centre via a mobile connection. The data is used for evaluation by a physician/technician for the patient's care.

TGA Public Summary