PACEMAKER, PROLITH 23U. PULSE GENERATOR

PACEMAKER, PROLITH 23U. PULSE GENERATOR is an FDA 510(k)-cleared medical device (K780238) manufactured by Edwards Pacemaker Systems. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on March 14, 1978. Regulation: 8.