PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F

PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F is an FDA 510(k)-cleared medical device (K884394) manufactured by Ela Medical, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on December 7, 1988. Regulation: 8.