Implantable stimulation device for neurological applications

Notified Body #

Internal CECP dossier #

Date of reception of the dossier

Field of expert panel

Medical device type

Implantable stimulation device for neurological applications.

This system has two implantable components: an implantable pulse generator and an electrode array and lead body.

Intended purpose

The device is intended for use as an adjunctive neurostimulation therapy in reducing the burden of epilepsy in adults over 18 years of age, with focal onset seizures that are refractory to two or more antiepileptic medications.

Risk class / type

Screening step:
appropriate medical field
/ competence area


Novelty of device
and/or of related clinical procedure