ANS AXXESS PERCUTANEOUS LEAD

ANS AXXESS PERCUTANEOUS LEAD is an FDA 510(k)-cleared medical device (K032034) manufactured by Advanced Neuromodulation Systems. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 2, 2003. Regulation: 8.