STELA MODEL BJ44 AND BJ45 PACING LEADS

STELA MODEL BJ44 AND BJ45 PACING LEADS is an FDA 510(k)-cleared medical device (K963738) 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 May 22, 1997. Regulation: 8.