BIFOCAL 2 8200 SERIES (A,B C,D)

BIFOCAL 2 8200 SERIES (A,B C,D) is an FDA 510(k)-cleared medical device (K800379) manufactured by American Pacemaker Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on September 25, 1980. Regulation: 8.