FOCUS J81F, J83F, J41F, J43F PACING LEADS

FOCUS J81F, J83F, J41F, J43F PACING LEADS is an FDA 510(k)-cleared medical device (K896742) 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 July 16, 1990. Regulation: 8.