PACESETTER SYSTEMS INC. ENDOCARDIAL FINNED LEAD

PACESETTER SYSTEMS INC. ENDOCARDIAL FINNED LEAD is an FDA 510(k)-cleared medical device (K851145) manufactured by Pacesetter Systems. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 18, 1985. Regulation: 8.