Indications for Use
Indications for Use
The Boston Scientific Precision Spectra™ Spinal Cord Stimulator System (Precision Spectra 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.
Refer to the Information for Prescribers manual for contraindications, warnings, precautions, adverse events summary, Physician Instructions, sterilization, component disposal, contact information for Boston Scientific, information regarding the Patient Identification card, FCC rules and clinical studies supporting clinical use of the neuromodulation system.
Refer to the following Directions for Use (DFU) for device specific instructions: Precision Spectra System Implantable Pulse Generator DFU, Surgical Leads DFU, Percutaneous Leads DFU, Precision Spectra System Clinician Remote Control DFU, Clinician Trial Manual, Precision Spectra System Programming Manual, and Programming Wand DFU.
Refer to the Limited Warranty for warranty information.
Indications for Use 90668223-01 Rev A 1 of 2
Loading...