Device Dossier

Patient Assistant PA96000 - Cardiac pulse generator reader, home-use

Device Dossier for Patient Assistant PA96000 - Cardiac pulse generator reader, home-use (Cardiac pulse generator reader, home-use, Class III, sponsor…

Intended purpose

The Patient Assistant is a hand-held, battery-operated telemetry device that enables the patient to activate the recording of cardiac information in the Reveal LINQ ICM while experiencing or immediately after a symptomatic event. The clinician uses the recorded information to determine if the symptoms were associated with a cardiac event.

Functional description

A hand-held,battery-operated telemetry device that enables the patient to activate the recording of cardiac information in the Reveal LINQ ICM while experiencing or immediately after a symptomatic event.

TGA Public Summary