PACEMAKER 147 VVI-THE OPTINIA

PACEMAKER 147 VVI-THE OPTINIA is an FDA 510(k)-cleared medical device (K840701) 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 May 1, 1984. Regulation: 8.