MEDTRONIC MDLS 3487/3487A/3587/3587A SCS LEADS

MEDTRONIC MDLS 3487/3487A/3587/3587A SCS LEADS is an FDA 510(k)-cleared medical device (K914433) manufactured by Medtronic Vascular. 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 22, 1991. Regulation: 8.