PACEMAKER PULSE GENERATOR W/ELECTRODE

PACEMAKER PULSE GENERATOR W/ELECTRODE is an FDA 510(k)-cleared medical device (K840353) manufactured by Ross Research, Inc.. 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 22, 1984. Regulation: 8.