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Neuromed, Inc.'s One-Step Connect™ Leads are intended to be used with Neuromed trial extensions and/or receivers, transmitters, and antennae to electrically stimulate spinal cord fiber tracts for treatment of chronic pain of the extremities and/or trunk. The proposed device modification does not affect the original intended use of the legally marketed device.

Neuromed, Inc.'s One-Step Connect™ Leads are implantable devices consisting of spaced electrodes connected by wires within a cover sheath. These percutaneous leads are introduced into the epidural space superior to the spinal segment responsible for pain impulse transmission, and connected to a radiofrequency (RF) receiver or pulse generator.