Device Dossier

Splitter 2 x 8 Kit - Electrode/lead, stimulator, implantable, neurological

Device Dossier for Splitter 2 x 8 Kit - Electrode/lead, stimulator, implantable, neurological (Neural-tissue electrical stimulation lead, Class III,…

Intended purpose

The Splitter 2x8 Kit is used with the Precision SCS system as an aid in the management of chronic intractable pain by delivering electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord, resulting in an inhibition of pain sensation.

Functional description

The Splitter 2x8 Kit is used to connect the infinion 16 contact lead to the Precision IPG. Only one Infinion 16 lead through one splitter 2x8 can be connected to a Precision IPG. The kit contains a torque wrench.

TGA Public Summary