ENDOCARDIAL SCREW-IN LEAD MODEL 1028T

ENDOCARDIAL SCREW-IN LEAD MODEL 1028T is an FDA 510(k)-cleared medical device (K902147) manufactured by Pacesetter Systems. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on July 16, 1990. Regulation: 8.