Device Dossier

SJM MRI Activator Handheld Device - Active-implantable-device communicator

Device Dossier for SJM MRI Activator Handheld Device - Active-implantable-device communicator (Active-implantable-device communicator, Class III, sponsor…

Intended purpose

The SJM Activator handheld device is used to evaluate the status of, and to enable and disable, the previously stored MRI settings. The activator is intended for use with St Jude Medical MR Conditional pulse generators.

Functional description

The St Jude Medical SJM MRI Activator handheld device model EX4000, is an external device that uses radio waves to communicate with a St Jude Medical MR Conditional implanted pulse generator. The activator enables and disables the pre-programmed MRI settings in the pulse generator.

TGA Public Summary