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
Aug 14, 2001
MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD
Medtronic Vascular
Cardiovascular
13d
Cleared
Aug 14, 2001
MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD
Medtronic Vascular
Cardiovascular
13d
Cleared
Aug 14, 2001
MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD
Medtronic Vascular
Cardiovascular
13d
Cleared
Aug 14, 2001
MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE
Medtronic Vascular
Cardiovascular
13d
Cleared
Aug 14, 2001
MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD
Medtronic Vascular
Cardiovascular
13d
Cleared
Feb 01, 2001
ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER
Zcv ,Inc.
Cardiovascular
21d
Cleared
Jan 08, 2001
ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER
Zcv ,Inc.
Cardiovascular
139d
Cleared
Dec 07, 2000
ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3
Zcv ,Inc.
Cardiovascular
115d
Cleared
Nov 09, 2000
ZYNERGY Z4 TRANSVENOUS BIPOLAR PACING CATHETER, MODEL 04-X-02-3-10-3
Zynergy Cardiovascular, Inc.
Cardiovascular
72d
Cleared
May 26, 1998
MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LEAD
Medtronic Vascular
Cardiovascular
260d
Cleared
Apr 10, 1998
TEMPORARY CARDIAC PACING WIRE
Ethicon, Inc.
Cardiovascular
60d
Cleared
Dec 29, 1997
INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610
Cardiac Control Systems, Inc.
Cardiovascular
230d
Cleared
Nov 18, 1997
SAFPACE SYSTEM
B.Braun Medical, Inc.
Cardiovascular
693d
Cleared
Oct 15, 1997
HARMAC TEMPORARY PACING CATHETER WITH BALLOON
Harmac Medical Products, Inc.
Cardiovascular
474d
Cleared
Aug 14, 1997
HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET
Harmac Medical Products, Inc.
Cardiovascular
412d
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