PERMATHANE 865 & 867 UNIPOLAR POLYURETH

PERMATHANE 865 & 867 UNIPOLAR POLYURETH is an FDA 510(k)-cleared medical device (K843703) 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 January 7, 1985. Regulation: 8.