510(k) K960281

IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY by Intermedics, Inc. — Product Code DTB

K960281 is an FDA 510(k) premarket notification submitted by Intermedics, Inc. for the device "IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY". The FDA issued a decision of ST on June 18, 1996. The device falls under product code DTB (Permanent Pacemaker Electrode), a Class III device regulated under 21 CFR 870.3680. Intermedics, Inc. has at least 10 other 510(k) clearances on record.