NEUROLOGICAL LEADS (PACKAGING MODIFICATION)

NEUROLOGICAL LEADS (PACKAGING MODIFICATION) is an FDA 510(k)-cleared medical device (K940416) 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 July 17, 1994. Regulation: 8.