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 Electro-Catheter Corp..
129
Total
129
Cleared
134d
Avg days
1978
Since
129 devices
Cleared
Jul 23, 1997
INTRODUCER SHEATH AND DILATOR
Boston Scientific Corp
Cardiovascular
114d
Cleared
Jul 22, 1997
MODEL 6495 BIPOLAR TEMPORARY PACING LEAD
Medtronic Vascular
Cardiovascular
298d
Cleared
Nov 13, 1996
UNIPOLAR IPG GROUND CABLE, MODEL 5473
Medtronic Vascular
Cardiovascular
205d
Cleared
Oct 17, 1996
ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER
Arrow Intl., Inc.
Cardiovascular
258d
Cleared
Oct 11, 1996
USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING
C.R. Bard, Inc.
Cardiovascular
301d
Cleared
Sep 17, 1996
RV PACING LEAD
Abbott Laboratories
Cardiovascular
84d
Cleared
Mar 15, 1996
FLEXON TEMPORARY CARDIAC PACER LEAD
Davis & Geck, Inc.
Cardiovascular
88d
Cleared
Dec 13, 1995
UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE MODEL 6494
Medtronic Vascular
Cardiovascular
55d
Cleared
Jul 27, 1995
MULTIPACE
Electro-Catheter Corp.
Cardiovascular
660d
Cleared
Feb 24, 1995
SILICORE SEMI-FLOATER
Electro-Catheter Corp.
Cardiovascular
507d
Cleared
Nov 23, 1992
UNIPOLAR ATRIAL TEMPORARY PACING LEAD, MODEL 6492
Medtronic Vascular
Cardiovascular
196d
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
Jan 27, 1992
PACEL(TM) FLOW DIRECTED PACING CATHETER
Daig Corp.
Cardiovascular
131d
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
Jun 20, 1989
DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER
Daig Corp.
Cardiovascular
123d
Cleared
Sep 06, 1988
BARD BAIM-TURI BALLOON DIAGNOSTIC PACING CATHETER
C.R. Bard, Inc.
Cardiovascular
92d
Cleared
Feb 12, 1988
DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODE
Daig Corp.
Cardiovascular
65d
Cleared
Nov 03, 1987
DEKNATEL TEMPORARY CARDIAC PACING WIRE
Deknatel, Inc.
Cardiovascular
48d
Cleared
Sep 25, 1987
TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500
Medtronic Vascular
Cardiovascular
415d
Cleared
Feb 26, 1986
FLEXON TEMPORARY CARDIAC CONDUCTIVE MULTIFILAMENT
Davis & Geck, Inc.
Cardiovascular
65d
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