IMPLANTABLE PROGRAM. CARDIAC PULSE GEN

IMPLANTABLE PROGRAM. CARDIAC PULSE GEN is an FDA 510(k)-cleared medical device (K831771) 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 August 15, 1983. Regulation: 8.