Device Dossier

Information system, patient record

Device Dossier for Information system, patient record (Information system, patient record, Class IIa, sponsor Medtronic). ARTG record, intended purpose,…

Intended purpose

The Medtronic Remote Monitors allows patients to gather information about their implanted cardiac device by placing an antenna over the device. This will transmit detailed information about their cardiac status via the remote monitor over a standard phone line to a secure server where their Doctor can view it via the internet. It does not reprogram the function of the implanted device.

TGA Public Summary