OPTIMA MDT PULSE GENERATOR W/TELEMETRY

OPTIMA MDT PULSE GENERATOR W/TELEMETRY is an FDA 510(k)-cleared medical device (K833798) 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 November 30, 1983. Regulation: 8.