EXTERNAL PULSE GENERATOR - EV4542

EXTERNAL PULSE GENERATOR - EV4542 is an FDA 510(k)-cleared medical device (K821791) manufactured by American Pacemaker Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 5, 1982. Regulation: 8.