Implantable stimulation device for neurological applications
Notified Body #
- 0344
Internal CECP dossier #
Date of reception of the dossier
- 30.05.2022
Field of expert panel
- Neurology
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
- class III implantable
Screening step:
appropriate medical field
/ competence area
Neurology
Novelty of device
and/or of related clinical procedure
- Device and Procedure are novel