
St. Jude Medical Neuromodulation
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OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS is an FDA 510(k)-cleared medical device (K112214) manufactured by St. Jude Medical Neuromodulation. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 16, 2011. Regulation: 8.