MODELS UL-804 AND BL-801 UNIPOLAR LEADS

MODELS UL-804 AND BL-801 UNIPOLAR LEADS is an FDA 510(k)-cleared medical device (K791552) manufactured by Pacesetter Systems. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on September 3, 1979. Regulation: 8.