Device Dossier

PRECISION Linear 8 Contact Leads (model SC-2138-xx)

Device Dossier for PRECISION Linear 8 Contact Leads (model SC-2138-xx) (Stimulator, electrical, analgesic, spinal cord, Class III, sponsor Boston…

Intended purpose

The PRECISION Linear 8 Contact Leads are a component of Boston Scientific’s Spinal Cord Stimulation (SCS) systems and are indicated as an aid in the management of chronic intractable pain.

Functional description

Precision electrode array leads have an 8-contact in-line design with the electrode contacts located near the distal end, each contact is 3 mm in length. Leads function as a component of Boston Scientific’s Spinal Cord Stimulation (SCS) systems by delivering electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord, resulting in an inhibition of pain sensation.

TGA Public Summary