Permanent Pacemaker Electrode
FDA product code DTB · 487 cleared devices
Class 3
Cardiovascular
- Regulation
- 21 CFR 870.3680
- Review panel
- CV
- Implant
- Yes
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1976-08-26 – 2006-07-10
DTB
2006-07-10
DTB
2004-08-06
PERMANENT PACING LEAD, MODEL PY2
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DTB
2004-04-07
PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU
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DTB
2003-05-22
MODEL 5071 MYOCARDIAL PACING LEAD
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DTB
2003-05-16
MODEL 4951M MYOCARDIAL UNIPOLAR LEAD
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DTB
2003-04-24
ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP
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DTB
2003-01-31
PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB
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DTB
2002-12-11
MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS
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DTB
2002-10-18
AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP
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DTB
2002-05-01
AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP
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DTB
2002-04-09
MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP
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DTB
2002-03-28
PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB
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DTB
2001-11-08
PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS
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DTB
2001-05-22
OSCOR PERMANENT PACING LEAD RZ MODEL SERIES
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DTB
2001-01-09
PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES
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DTB
2000-06-02
ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668
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DTB
2000-04-13
EX 45-BP, MODEL 330 132; EX 53-BP, MODEL 130 018; EX 60-BP, MODEL 330 133
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DTB
2000-04-10
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS
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DTB
2000-04-06
PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051
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DTB
2000-04-04
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS
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DTB
1999-12-17
YP 45/15-BP; YP 53/15-BP; YP 60/15-BP
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DTB
1999-07-30
HT, MODEL HT PB
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DTB
1999-07-01
SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854
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DTB
1999-06-03
RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777
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DTB
1998-09-10
SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120 444, 119 684, 120 438 AND 120 143
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DTB
1998-07-22
RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL NUMBERS 124 396, 124 397, 124 395, 124 000
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DTB
1998-03-04
TIR/TIJ AND POLYROX
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DTB
1998-02-23
LOCATOR MODEL 4036
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DTB
1998-01-27
ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606
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DTB
1998-01-08
STELA MODEL UJ45 PACING LEADS
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DTB
1997-05-23
STELA MODEL BJ44 AND BJ45 PACING LEADS
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DTB
1997-04-01
OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR
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DTB
1997-03-10
BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION
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DTB
1996-12-16
MODEL 430-07 ENDOCARDIAL PACING LEAD
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DTB
1996-11-04
INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD
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DTB
1996-09-27
UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION & PASSIVE FIXATION
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DTB
1996-08-22
MEDTRONIC MODEL 5058 BIPOLAR, IMPLANTABLE, SCREW-IN, VENTRICULAR/ATRIAL, TRANSVENOUS LEAD
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DTB
1996-08-21
BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)
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DTB
1996-08-15
MODEL 2188 CORONARY SINUS LEAD.
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DTB
1996-07-30
TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS/TRANSVENOUS, PERMANENT SCREW-IN PACING LEADS
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DTB
1996-07-15
MAXIM PF MODELS 033-581/033-590
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DTB
1996-06-24
STERILIZATION
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DTB
1996-06-19
CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD
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DTB
1996-06-18
IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY
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DTB
1996-02-27
INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD
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DTB
1996-02-01
AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION)
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DTB
1995-12-26
DF-1 TERMINAL CAP
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DTB
1995-11-07
MODELS 5866-45 AND 5866-46 SIZING SLEEVE
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DTB
1995-10-12
TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS
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DTB
1995-08-31
PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING
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DTB
1995-08-31
PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING
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DTB
1995-06-29
TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD
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DTB
1994-11-04
MEDTRONIC MODEL 4558M
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DTB
1994-08-08
AFP CARDIAC PACING SYSTEM MODEL 283
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DTB
1994-07-15
PACING LEAD MODEL 1188T
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DTB
1994-07-06
PASSIVE PLUS ENDOCARDIAL PACING LEADS VAR. MODELS
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DTB
1994-06-15
SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146T
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DTB
1994-05-02
MEDTRONIS(R) PACING LEADS AND LEAD ADAPTORS, MODIF
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DTB
1994-03-21
MEDTRONIC MODEL 5028 TARGET TIP, BIPOLAR, IMPLANTABLE, TINED, VENTRICULAR, TRANSVENOUS LEAD
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DTB
1993-12-08
MEDTRONIC MODELS 4057M,4058M,4557M, PACING LEADS
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DTB
1993-11-24
VASCOTWIST 9/60
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DTB
1993-09-23
MEDTRONIC MODEL 4081,4581,4582 TARGET TIP PACING L
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DTB
1993-08-25
VASCO TIP/VASCOFLANGE
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DTB
1993-08-24
VASCOSCREW 6/60 AND VASCOSCREW 8/60
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DTB
1993-08-03
MAXIMA FILTERED HARDSHELL RESERVOIR
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DTB
1993-06-22
POSSIS MEDICAL MYOPORE BIPOLAR SUTURELESS MYCARDIA
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DTB
1993-06-10
MODEL 1148T TRANSVENOUS, SCREW-IN LEAD
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DTB
1993-04-29
CARDIFIX ENDOCARDIAL PACING LEAD
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DTB
1993-01-22
MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD
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DTB
1993-01-22
CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE
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DTB
1992-12-03
MEDTRONIC MODELS 5069 AND 5071 MYOCARDIAL PACING
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DTB
1992-09-11
MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD
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DTB
1992-08-17
NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING
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DTB
1992-05-22
MODELS 6917T, 6917AT & 4951M EPICARDIAL PACE LEADS
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DTB
1992-02-11
PERMANENT CARDIAC PACING LEADS AND ADAPTORS
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DTB
1992-02-04
OSCOR MEDICAL CORP PERMANENT PACING LEAD
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DTB
1992-01-27
PERMANENT PACING PAD, MODIFICATION
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DTB
1992-01-27
PERMANENT PACING LEADS, MODIFICATION
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DTB
1991-10-17
MEDTRONIC UNIPOLAR, POLY PAC LEAD-BARR COAT COILS
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DTB
1991-09-23
IMPLANT PACING LEAD, RETRACTABLE, MODIFICATION
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DTB
1991-09-23
OSCOR MEDICAL FIX SCREW PAC LEAD/PEEL CATH, MODIF
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DTB
1991-09-23
MODEL KY PACEMAKER LEAD-VARIOUS, MODIFICATION
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DTB
1991-09-23
IMPLANT PACING LEAD TINED #3390, MODIFICATION
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DTB
1991-09-23
IMPLANT PACING LEAD, TINED #3262, MODIFICATION
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DTB
1991-09-23
PRODUCTS IMPLANT PACING LEAD, TINED, MODIFICATION
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DTB
1991-09-23
MODIFIED OSCOR PY PACING LEADS/MODIFICATION
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DTB
1991-09-18
MODELS 432-03 & 433-03 IMPLANT ENDOCARD PAC LEAD
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DTB
1991-08-28
100 CM PERMANENT PACING LEAD MODELS
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DTB
1991-08-28
ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE
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DTB
1991-08-28
PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIP
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DTB
1991-08-09
BIPOLAR SUTURELESS MYOCARDIAL PACING LEADS
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DTB
1991-07-30
PERMANENT IMPLANTABLE FH ENDOCARDIAL LEADS W/TIP
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DTB
1991-05-07
PERMANENT PACING LEAD
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DTB
1991-05-07
OSCOR MEDICAL CORP. PERMANENT PACING PAD
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DTB
1991-04-22
INTERMEDICS MODEL 431-11 IMPLANT ENDOCARD PAC LEAD
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DTB
1991-03-01
INTERMEDICS 430-07 BIPOL IMPLANT ENDOCARD PAC LEAD
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DTB
1991-01-18
FOCUS T41,T41F,T43, T43F,T44F
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DTB
1991-01-08
LASERDISH POLY UNIPOLAR VENTRI LEAD W/TRAIL TINES
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DTB
1990-11-08
LASERDISH SILICONE VENTRICULAR LEAD W/TRAILING TIN
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DTB
1990-10-16
LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 60-UP
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