MODIFIED MODEL 5330 AV DEMAND PULSE GENERATOR

MODIFIED MODEL 5330 AV DEMAND PULSE GENERATOR is an FDA 510(k)-cleared medical device (K910237) 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 February 24, 1991. Regulation: 8.