User's Manual

Precision Spectra™ System Information for Patients
90668560-01 Rev B 2 of 32
Safety Information
Indications for Use
The Boston Scientifi c Precision Spectra™ 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 Spectra System Clinical Summary
Determination of the safety and effectiveness of the Precision Spectra System was based on
available published clinical studies for similar implanted spinal cord stimulation systems. The
Precision Spectra 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 Spectra System for the treatment chronic intractable pain of the
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