Device Dossier

BIOMONITOR IIIm - Implantable cardiac monitor

Device Dossier for BIOMONITOR IIIm - Implantable cardiac monitor (Implantable cardiac monitor, Class III, sponsor Biotronik). ARTG record, intended…

Intended purpose

BIOMONITOR IIIm is the product name of an implantable cardiac rhythm monitoring system that records subcutaneous ECGs. Recording is activated both automatically and by the patient.

Functional description

It continuously and automatically records and monitors the heart rhythm. Depending on the preset parameters, subcutaneous ECGs, and other data may be recorded. The patient can also trigger the recording of subcutaneous ECGs using the Remote Assistant III accessory if subjectively symptomatic episodes occur. The recordings can be transmitted to the BIOTRONIK Home Monitoring Service Center. This enables physicians to perform complete diagnosis management. MR conditional.

TGA Public Summary