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 14, 1995
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, MODEL 6491
The Heart Valve Div. Medtronic Cardiovascular Surg
Cardiovascular
280d
Cleared
Jul 14, 1995
TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500
Medtronic Blood Systems, Inc.
Cardiovascular
280d
Cleared
Jul 14, 1995
UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492
Medtronic Blood Systems, Inc.
Cardiovascular
276d
Cleared
Feb 24, 1995
SILICORE SEMI-FLOATER
Electro-Catheter Corp.
Cardiovascular
507d
Cleared
Jan 28, 1994
BIPOLAR BALLOON PACING CATHETER BY J-LLOYD
J-Lloyd Medical, Inc.
Cardiovascular
387d
Cleared
Oct 21, 1993
ANGEMED MODEL 4000 QC BIPOLAR TEMP PACING LEAD
Angemed, Inc.
Cardiovascular
416d
Cleared
Aug 25, 1993
ANGEMED 5000 LEAD ADAPTER
Angemed, Inc.
Cardiovascular
359d
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
Nov 23, 1992
UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE, 6493
The Heart Valve Div. Medtronic Cardiovascular Surg
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
Dec 27, 1991
XEMEX TEMPORARY PACING CATHETER A MODIFIED
Zeon Medical Corp.
Cardiovascular
143d
Cleared
May 16, 1991
XEMEX TEMPORARY PACING CATHETER A
Zeon Medical Corp.
Cardiovascular
199d
Cleared
Oct 16, 1990
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, #6491
Medtronic Vascular
Cardiovascular
144d
Cleared
Apr 19, 1990
E-CLIP
Joel Cohen & Esther R. Cohen
Cardiovascular
48d
Cleared
Dec 07, 1989
UNIPOLAR TEMP. MYOCARDIAL HEART WIRE, MODEL 6490
Medtronic Vascular
Cardiovascular
70d
Cleared
Aug 25, 1989
MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE
Pace Medical
Cardiovascular
179d
Cleared
Jun 20, 1989
DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER
Daig Corp.
Cardiovascular
123d
Cleared
Mar 22, 1989
TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1
Oscor Medical Corp.
Cardiovascular
121d
Cleared
Sep 06, 1988
BARD BAIM-TURI BALLOON DIAGNOSTIC PACING CATHETER
C.R. Bard, Inc.
Cardiovascular
92d
Cleared
Jul 12, 1988
HIGH TORQUE TEMPORARY PERVENOUS LEAD W/DEPTH MARK
Cordis Leads, Inc.
Cardiovascular
57d
Cleared
May 19, 1988
EXTERNAL PACEMAKER WIRE DRESSING CHANGE
Neal & Assoc., Inc.
Cardiovascular
52d
Cleared
Feb 12, 1988
DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODE
Daig Corp.
Cardiovascular
65d