IMPLANTABLE PACEMAKER LEAD ADAPTER

IMPLANTABLE PACEMAKER LEAD ADAPTER is an FDA 510(k)-cleared medical device (K810245) manufactured by Intermedics, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 3, 1981. Regulation: 8.