BIOPOLAR TINED ENDOCARDIAL LEAD 403B/60

BIOPOLAR TINED ENDOCARDIAL LEAD 403B/60 is an FDA 510(k)-cleared medical device (K820767) manufactured by Siemens Elema AB. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on April 8, 1982. Regulation: 8.