MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR

MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR is an FDA 510(k)-cleared medical device (K861368) 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 August 3, 1986. Regulation: 8.