Device Dossier
Lead Kit - Stimulator, electrical, analgesic, spinal cord
Device Dossier for Lead Kit - Stimulator, electrical, analgesic, spinal cord (Stimulator, electrical, analgesic, spinal cord, Class III, sponsor Nevro…
- GMDN category: Stimulator, electrical, analgesic, spinal cord
Intended purpose
The Lead Kit is a part of the Nevro Spinal Cord Stimulation System which is intended to aid in the management of chronic intractable pain of the truck and/or limbs. The Leads are chronically implanted with most of their length in the epidural space, near the spine. The proximal end of the lead will be connected either to a lead extension or an IPG.
Functional description
The Nevro family of leads has eight electrodes located near the distal end of each lead. The lead body is made of medical grade polyurethane with a stiffer proximal end to aid insertion into the connector of a lead extension or implantable pulse generator. The components of the kit include lead anchor, insertion needle, coiled lead blank, OR cable, OR cable extension and OR cable extension connector.