510(k) K963738

STELA MODEL BJ44 AND BJ45 PACING LEADS by Ela Medical, Inc. — Product Code DTB

K963738 is an FDA 510(k) premarket notification submitted by Ela Medical, Inc. for the device "STELA MODEL BJ44 AND BJ45 PACING LEADS". The FDA issued a decision of PT on May 23, 1997. The device falls under product code DTB (Permanent Pacemaker Electrode), a Class III device regulated under 21 CFR 870.3680. Ela Medical, Inc. has at least 10 other 510(k) clearances on record.