MEDTRONIC MODEL 5328 PROGRAM-STIMULATOR

MEDTRONIC MODEL 5328 PROGRAM-STIMULATOR is an FDA 510(k)-cleared medical device (K851091) manufactured by Medtronic Vascular. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 15, 1985. Regulation: 8.