FDA Product Code DTB: Permanent Pacemaker Electrode
Leading manufacturers include Medtronic Vascular, Intermedics, Inc. and Cordis Corp..
487
Total
479
Cleared
119d
Avg days
1976
Since
FDA 510(k) Cleared Permanent Pacemaker Electrode Devices (Product Code DTB)
487 devices
Cleared
May 22, 2003
MODEL 5071 MYOCARDIAL PACING LEAD
Medtronic Vascular
Cardiovascular
30d
Not Cleared
Dec 16, 1996
MODEL 430-07 ENDOCARDIAL PACING LEAD
Intermedics, Inc.
Cardiovascular
439d
Cleared
Nov 04, 1996
INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD
Intermedics, Inc.
Cardiovascular
361d
Cleared
Aug 22, 1996
MEDTRONIC MODEL 5058 BIPOLAR, IMPLANTABLE, SCREW-IN, VENTRICULAR/ATRIAL, TRANSVENOUS LEAD
Medtronic Vascular
Cardiovascular
90d
Cleared
Aug 21, 1996
BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)
Intermedics, Inc.
Cardiovascular
77d
Cleared
Aug 15, 1996
MODEL 2188 CORONARY SINUS LEAD.
Medtronic Vascular
Cardiovascular
87d
Cleared
Jul 30, 1996
TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS/TRANSVENOUS, PERMANENT SCREW-IN PACING LEADS
Medtronic Vascular
Cardiovascular
90d
Cleared
Jun 19, 1996
CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD
Intermedics, Inc.
Cardiovascular
197d
Cleared
Jun 18, 1996
IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY
Intermedics, Inc.
Cardiovascular
151d
Cleared
Feb 27, 1996
INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD
Intermedics, Inc.
Cardiovascular
137d
Cleared
Nov 07, 1995
MODELS 5866-45 AND 5866-46 SIZING SLEEVE
Medtronic Vascular
Cardiovascular
71d
Cleared
Oct 12, 1995
TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS
Medtronic Vascular
Cardiovascular
174d
Cleared
Nov 04, 1994
MEDTRONIC MODEL 4558M
Medtronic Vascular
Cardiovascular
261d
Not Cleared
May 02, 1994
MEDTRONIS(R) PACING LEADS AND LEAD ADAPTORS, MODIF
Medtronic Vascular
Cardiovascular
340d
Cleared
Mar 21, 1994
MEDTRONIC MODEL 5028 TARGET TIP, BIPOLAR, IMPLANTABLE, TINED, VENTRICULAR, TRANSVENOUS LEAD
Medtronic Vascular
Cardiovascular
231d
Cleared
Dec 08, 1993
MEDTRONIC MODELS 4057M,4058M,4557M, PACING LEADS
Medtronic Vascular
Cardiovascular
217d
Cleared
Sep 23, 1993
MEDTRONIC MODEL 4081,4581,4582 TARGET TIP PACING L
Medtronic Vascular
Cardiovascular
188d
Cleared
Aug 03, 1993
MAXIMA FILTERED HARDSHELL RESERVOIR
Medtronic Vascular
Cardiovascular
85d
Cleared
Apr 29, 1993
CARDIFIX ENDOCARDIAL PACING LEAD
Intermedics, Inc.
Cardiovascular
363d
Cleared
Jan 22, 1993
MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD
Intermedics, Inc.
Cardiovascular
217d
Cleared
Dec 03, 1992
MEDTRONIC MODELS 5069 AND 5071 MYOCARDIAL PACING
Medtronic Vascular
Cardiovascular
349d
Cleared
May 22, 1992
MODELS 6917T, 6917AT & 4951M EPICARDIAL PACE LEADS
Medtronic Vascular
Cardiovascular
102d
Cleared
Feb 11, 1992
PERMANENT CARDIAC PACING LEADS AND ADAPTORS
Medtronic Vascular
Cardiovascular
252d
Cleared
Oct 17, 1991
MEDTRONIC UNIPOLAR, POLY PAC LEAD-BARR COAT COILS
Medtronic Vascular
Cardiovascular
85d