510(k) K023803

MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS by Biotronik, Inc. — Product Code DTB

K023803 is an FDA 510(k) premarket notification submitted by Biotronik, Inc. for the device "MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS". The FDA issued a decision of Substantially Equivalent on December 11, 2002. 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.