
Advanced Neuromodulation Systems
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ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT is an FDA 510(k)-cleared medical device (K053250) 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 December 14, 2005. Regulation: 8.