PERMANENT ENDOCARD. UNIPOLAR TINED LEAD

PERMANENT ENDOCARD. UNIPOLAR TINED LEAD is an FDA 510(k)-cleared medical device (K812905) manufactured by Diag Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on February 3, 1982. Regulation: 8.