510(k) K123299

MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS by St. Jude Medical Neuromodulation — Product Code GZB

K123299 is an FDA 510(k) premarket notification submitted by St. Jude Medical Neuromodulation for the device "MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS". The FDA issued a decision of Substantially Equivalent on January 18, 2013. The device falls under product code GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief)), a Class II device regulated under 21 CFR 882.5880. St. Jude Medical Neuromodulation has at least 1 other 510(k) clearance on record.