FDA Product Code LDF: Electrode, Pacemaker, Temporary
Temporary pacemakers provide immediate cardiac pacing during hemodynamic emergencies. FDA product code LDF covers temporary pacemaker electrodes used for short-term cardiac stimulation.
These catheters are placed transvenously or epicardially to deliver electrical impulses to the myocardium for temporary rate support during symptomatic bradycardia, post-cardiac surgery, and as a bridge to permanent pacemaker implantation.
LDF devices are Class II medical devices, regulated under 21 CFR 870.3680 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include Medtronic Vascular, C.R. Bard, Inc. and Cordis Corp..
128
Total
128
Cleared
132d
Avg days
1978
Since
128 devices
Cleared
Nov 23, 1992
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD MOD. 6491
Medtronic Vascular
Cardiovascular
193d
Cleared
Oct 19, 1992
MEDTRONIC MODELS 5455L AND 5455SL SURGICAL CABLES
Medtronic Vascular
Cardiovascular
101d
Cleared
Oct 16, 1990
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, #6491
Medtronic Vascular
Cardiovascular
144d
Cleared
Dec 07, 1989
UNIPOLAR TEMP. MYOCARDIAL HEART WIRE, MODEL 6490
Medtronic Vascular
Cardiovascular
70d
Cleared
Sep 06, 1988
BARD BAIM-TURI BALLOON DIAGNOSTIC PACING CATHETER
C.R. Bard, Inc.
Cardiovascular
92d
Cleared
Sep 25, 1987
TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500
Medtronic Vascular
Cardiovascular
415d
Cleared
Oct 11, 1985
MEDTRONIC MODEL 6405
Medtronic Vascular
Cardiovascular
29d
Cleared
Sep 16, 1985
CORDIS HIGH-TORQUE TEMP. PERVENOUS LEAD W/DEPTH MA
Cordis Corp.
Cardiovascular
138d
Cleared
Sep 16, 1985
115-GK BARD CARE TRANSLU VENTRICULAR PACING LEAD
C.R. Bard, Inc.
Cardiovascular
96d
Cleared
Apr 24, 1984
LUMELEC ELECTRODE CATHETER
Cordis Corp.
Cardiovascular
131d
Cleared
Oct 19, 1983
EPCOR MULTIELECTRODE TEMP. PERVENOUS
Cordis Corp.
Cardiovascular
79d
Cleared
Feb 18, 1983
USCI TEMP. ATRIO-VENTRICULAR ELECTRODE
C.R. Bard, Inc.
Cardiovascular
38d
Cleared
Nov 16, 1981
MODEL 5867-12 BIPOLAR LOW-PROFILE LEAD
Medtronic Vascular
Cardiovascular
49d
Cleared
Oct 29, 1981
TEMPORARY PERVENOUS J-ATRIAL LEAD
Cordis Corp.
Cardiovascular
24d
Cleared
Sep 21, 1981
USCI TRANSTHORACIC TEMP. PACING ELECTROD
C.R. Bard, Inc.
Cardiovascular
35d
Cleared
Jul 20, 1981
TEMPORARY ENDOCARDIAL TRIPOLAR LD. #6880
Medtronic Vascular
Cardiovascular
69d
Cleared
Apr 08, 1981
TEMPTRON #'S 6804/6805
Medtronic Vascular
Cardiovascular
28d
Cleared
Feb 05, 1981
CORDIS TEMPORATY CURVED ATRIAL LEAD
Cordis Corp.
Cardiovascular
29d
Cleared
Apr 16, 1980
USCI BIPOLAR BALLON PACING ELECTRODE
C.R. Bard, Inc.
Cardiovascular
65d