PACESETTER SYSTEMS, ENDOCARDIAL FIRM LEAD

PACESETTER SYSTEMS, ENDOCARDIAL FIRM LEAD is an FDA 510(k)-cleared medical device (K850652) 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 9, 1985. Regulation: 8.