510(k) K063080

TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS by Advanced Neuromodulation Systems — Product Code GZB

K063080 is an FDA 510(k) premarket notification submitted by Advanced Neuromodulation Systems for the device "TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS". The FDA issued a decision of Substantially Equivalent on December 12, 2006. The device falls under product code GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief)), a Class II device regulated under 21 CFR 882.5880. Advanced Neuromodulation Systems has at least 10 other 510(k) clearances on record.