FASTPASS IMPLANTABLE ENDOCARDIAL PAC

FASTPASS IMPLANTABLE ENDOCARDIAL PAC is an FDA 510(k)-cleared medical device (K841885) 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 August 2, 1984. Regulation: 8.