510(k) K994240

EX 45-BP, MODEL 330 132; EX 53-BP, MODEL 130 018; EX 60-BP, MODEL 330 133 by Biotronik, Inc. — Product Code DTB

K994240 is an FDA 510(k) premarket notification submitted by Biotronik, Inc. for the device "EX 45-BP, MODEL 330 132; EX 53-BP, MODEL 130 018; EX 60-BP, MODEL 330 133". The FDA issued a decision of ST on April 13, 2000. The device falls under product code DTB (Permanent Pacemaker Electrode), a Class III device regulated under 21 CFR 870.3680. Biotronik, Inc. has at least 10 other 510(k) clearances on record.