Device Dossier
Infinion CX Lead - Stimulator, electrical, analgesic, spinal cord
Device Dossier for Infinion CX Lead - Stimulator, electrical, analgesic, spinal cord (Stimulator, electrical, analgesic, spinal cord, Class III, sponsor…
- GMDN category: Stimulator, electrical, analgesic, spinal cord
Intended purpose
The Infinion™ CX lead will be used with the Precision and Precision Spectra Spinal Cord Stimulation (SCS) Systems as an aid in the management of chronic intractable pain. As a component of these SCS systems, the Infinion™ CX lead is used to deliver electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord, resulting in an inhibition of pain sensation. This is intended to be used for the permanent implant phase.
Functional description
The Infinion™ CX lead functions as a component of the Precision and Precision Spectra Spinal Cord Stimulation (SCS) Systems. Each Infinion™ CX lead has 16 contacts located near the distal end and two tails with 8 proximal contacts. The Infinion™ CX lead may be inserted directly into the 8-contact OR cables or IPG ports. The kit also contains suture sleeves, steering cap and lead positioning labels.