GENERATOR, PULSE, CARDIAC, IMPLANTABLE

GENERATOR, PULSE, CARDIAC, IMPLANTABLE is an FDA 510(k)-cleared medical device (K780421) manufactured by Telectronics, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on July 6, 1978. Regulation: 8.