User Manual

Introduction
3
a lead to externalize the lead for a trial phase or to extend a lead when
a permanent IPG is implanted.
Indications for Use
The Advanced Bionics Precision
™
Spinal Cord Stimulator System
(Precision System) is indicated as an aid in the management of
chronic intractable pain of the trunk and/or limbs, including unilateral
or bilateral pain associated with the following: failed back surgery
syndrome, intractable low back pain and leg pain.
Precision System Clinical Summary
Determination of the safety and effectiveness of the PRECISION Sys-
tem was based on available published clinical studies for similar
implanted spinal cord stimulation systems. The PRECISION System
is similar to the SCS systems reported in published literature in
intended use, target patient population, technology, device design, and
output characteristics. Therefore, the clinical data from the published
literature described below represents evidence supporting the safety
and effectiveness of the PRECISION System for the treatment
chronic intractable pain of the trunk and/or limbs, including unilateral