510(k) K140972

UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACING by Medtronic, Inc. — Product Code LDF

K140972 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACING". The FDA issued a decision of Substantially Equivalent on June 6, 2014. The device falls under product code LDF (Electrode, Pacemaker, Temporary), a Class II device regulated under 21 CFR 870.3680. Medtronic, Inc. has at least 10 other 510(k) clearances on record.