DTB · Class III · 21 CFR 870.3680

FDA Product Code DTB: Permanent Pacemaker Electrode

Leading manufacturers include Intermedics, Inc., Medtronic Vascular and Cordis Corp..

487
Total
479
Cleared
119d
Avg days
1976
Since
487 devices
121–144 of 487
Cleared Mar 27, 1985
CORDIS ENCOR PERVENOUS ATRIAL & VENTRICULAR LEADS
K844970
Cordis Corp.
Cardiovascular · 93d
Cleared Jan 18, 1985
TRANSVENOUS TINED VENTRICULAR/ATRIAL
K842031
Medtronic Vascular
Cardiovascular · 245d
Cleared Jan 18, 1985
MODELS 4012/4512 TRANSVENOUS TINED-
K842032
Medtronic Vascular
Cardiovascular · 245d
Cleared Jan 10, 1985
MEDTRONIC 6304, 6305,6306,6506 & 6506W. TEMP.PACIN
K844959
Medtronic Vascular
Cardiovascular · 20d
Cleared Jan 08, 1985
MEDTRONIC 6957J
K843707
Medtronic Vascular
Cardiovascular · 109d
Cleared Dec 27, 1984
CORDIS ENCOR ATRIAL LEAD
K811259
Cordis Corp.
Cardiovascular · 1331d
Cleared Dec 27, 1984
MEDTRONIC 6957
K843706
Medtronic Vascular
Cardiovascular · 97d
Cleared Sep 24, 1984
LIFELINE TLE 476-04
K843393
Intermedics, Inc.
Cardiovascular · 26d
Cleared Sep 24, 1984
LIFELINE TLE 484-02
K843394
Intermedics, Inc.
Cardiovascular · 26d
Cleared Aug 12, 1983
LIFELINE PACING LEADS #471-07 &09
K832409
Intermedics, Inc.
Cardiovascular · 22d
Cleared Jul 26, 1983
MEDTRONIC MODELS 4012 & 4512
K832099
Medtronic Vascular
Cardiovascular · 27d
Cleared Apr 18, 1983
LIFELINE ENDOCARDIAL PACING LEAD #479-05
K830782
Intermedics, Inc.
Cardiovascular · 38d
Cleared Feb 28, 1983
LIFELINE UNIPOLAR J-LEAD #483-05
K830463
Intermedics, Inc.
Cardiovascular · 10d
Cleared Jan 14, 1983
LIFELINE -UNIPOLAR LEAD #487-05
K823508
Intermedics, Inc.
Cardiovascular · 49d
Cleared Nov 30, 1982
MEDTRONIC MODELS 4011 & 4511
K822781
Medtronic Vascular
Cardiovascular · 77d
Cleared Aug 06, 1982
MEDTRONIC #6993
K820989
Medtronic Vascular
Cardiovascular · 121d
Cleared Aug 06, 1982
POROUS SURFACED PLATINUM IRIDIUM
K821889
Cordis Corp.
Cardiovascular · 42d
Cleared Apr 16, 1982
IMPLANTIBLE SUTURE SLEEVE
K820487
Intermedics, Inc.
Cardiovascular · 52d
Cleared Dec 10, 1981
POLY-FLEX PACING LEADS
K813028
Intermedics, Inc.
Cardiovascular · 43d
Cleared Nov 16, 1981
INTERMEDICS POLYFLEX-MODEL 493-03 LEAD
K812989
Intermedics, Inc.
Cardiovascular · 21d
Cleared Nov 16, 1981
INTERMEDICS POLYFLEX-MODEL 483-03 LEAD
K812990
Intermedics, Inc.
Cardiovascular · 21d
Cleared Nov 16, 1981
INTERMEDICS POLYFLEX-MODEL 483-04 LEAD
K812991
Intermedics, Inc.
Cardiovascular · 21d
Cleared Oct 23, 1981
MEDTRONIC #4951
K812599
Medtronic Vascular
Cardiovascular · 39d
Cleared Oct 06, 1981
INTERMEDICS POLY FLEX EPICARDIAL SUTURE
K812221
Intermedics, Inc.
Cardiovascular · 60d