This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: PRECISION™ Spinal Cord Stimulator (SCS) System
Applicant: Advanced Bionics Corporation
Address: 12740 San Fernando Road, Sylmar, California 91342-3700
Approval Date: April 27, 2004
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf3/p030017a.pdf
What is it? The PRECISION™ Spinal Cord Stimulator (SCS) System is a neurostimulation device that transmits electrical signals to the spinal cord to decrease chronic pain in the body, arms and legs.
The device consists of two parts:
- a stimulator device (signal generator) implanted under the skin that transmits electrical signals to the spinal cord through an insulated lead wire, and
- an external remote control that programs the treatment delivered by the signal generator.
How does it work?
- The implanted signal generator receives radio signals from the remote control.
- The radio signals tell the signal generator when and what kind of stimulation to deliver to the spinal cord.
The external remote control is battery operated and can be controlled by the patient or a health care provider.
When is it used? The Precision™ SCS System is used as an aid in the management of:
- difficult to treat chronic pain of the body and limbs,
- pain associated with failed back surgery syndrome,
- low back pain,
- and leg pain.
What will it accomplish? The Precision™ SCS System may decrease difficult to treat chronic pain in the body, arms, and legs.
When should it not be used? Spinal cord stimulation should not be used on patients who:
- are considered by their physician to be poor surgical risks,
- are pregnant,
- are unable to operate the system,
- ail to receive effective pain relief during trial stimulation.
Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p030017