UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M

UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M is an FDA 510(k)-cleared medical device (K871208) 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 June 4, 1987. Regulation: 8.