MEDTRONIC MODELS 3983A AND 3983B RESUME LEADS

MEDTRONIC MODELS 3983A AND 3983B RESUME LEADS is an FDA 510(k)-cleared medical device (K921558) 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 6, 1992. Regulation: 8.