Device Dossier

Merlin 2 Patient Care System (PCS) Model MER3700 - Cardiac pulse generator programmer

Device Dossier for Merlin 2 Patient Care System (PCS) Model MER3700 - Cardiac pulse generator programmer (Cardiac pulse generator programmer, Class III,…

Intended purpose

To interrogate, program, display data and test cardiac implantable devices and leads to help physicians and clinicians monitor, diagnose, record heart rhythms, and program devices, which include pacemakers, implantable cardioverter-defibrillators (ICDs), cardiac resynchronisation therapy (CRT) devices, and implantable cardiac monitors (ICMs), during implant, revision, explant or follow-up sessions.

Functional description

The Merlin 2 Patient Care System (PCS) is designed for use by clinicians to interrogate, program, display data and test cardiac implantable devices and leads to help physicians and clinicians monitor, diagnose, record heart rhythms, and program devices, which include pacemakers, ICDs, CRT devices, and ICMs, during implant, revision, explant or follow-up sessions.

TGA Public Summary