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
1990-10-16
DTB
1990-10-16
LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 45-UP
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DTB
1990-09-26
MODELS 5069/5071 MYOCARDIAL PACING LEADS
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DTB
1990-08-08
LASERDISH POLYURETHANE VENTRICULAR LEAD W/TRAILING
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DTB
1990-08-08
BIOTRONIK'S PS-ENDOCARDIAL LEADS
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DTB
1990-07-17
ENDOCARDIAL SCREW-IN LEAD MODEL 1028T
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DTB
1990-07-17
FOCUS J81F, J83F, J41F, J43F PACING LEADS
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DTB
1990-06-12
VS-1 LEAD EXT. 033-302, 4.75MM 033-260, 033-458
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DTB
1990-05-22
DNP 60-B UNIPOLAR ENDOCARDIAL LEAD
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DTB
1990-05-03
MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1
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DTB
1990-04-20
FAST-PASS ACE MODELS 1212T/1222T/1216T/1226T
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DTB
1990-03-06
MEDTRONIC IMPLANTABLE PACING LEADS W/IS-1 CONN.
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DTB
1990-02-08
PERMANENT AND TEMP. PACEMAKER ELECTRODE & LEAD ADA
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DTB
1990-02-05
MODIFIED J-STIFFENER WIRE MATERIAL IN LEAD LINES
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DTB
1990-01-18
FIVE-YEAR STERILE PACKAGING SHELF LIFE
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DTB
1989-12-20
MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS
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DTB
1989-12-20
ENDOCARDIAL SCREW-IN LEAD MODEL 1020T
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DTB
1989-11-14
NEW ADHESIVE, PELLETHAN ON POLYURETHANE LEADS-MODI
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DTB
1989-07-14
IMPLANTABLE PACING LEADS W/IS-1 CONN., UNIPOLAR
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DTB
1989-07-14
MODELS 1113 AND 1114 PACEMAKER LEADS
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DTB
1989-07-14
MYOPORE(TM) UNIPOLAR SUTURELESS MYOCARDIAL LEADS
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DTB
1989-06-20
PACEMAKER LEAD ADAPTER
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DTB
1989-06-05
CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE
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DTB
1989-05-31
MEDTRONIC MODEL 5866-45 SIZING SLEEVE
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DTB
1989-04-21
ALTERNATE PACKAGING CONFIGURATION FOR PACING LEADS
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DTB
1989-04-19
HEPARIN BONDING FOR CATHETERS
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DTB
1989-03-28
MODELS 430-07 & 431-07 IMPLANTABLE PACING LEADS
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DTB
1989-03-28
MODELS 432-03 & 433-03 IMPLANTABLE PACING LEADS
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DTB
1989-03-22
SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERS
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DTB
1989-02-22
ACCUFIX AND LASERDISH BIPOLAR VS-1 LEADS
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DTB
1989-02-10
MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIVE FIX. LEAD
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DTB
1989-02-02
VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE)
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DTB
1989-01-30
MODEL 6208,6209,6210,6211,6212,6214 (PLI'S)
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DTB
1989-01-17
MEDTRONIC MODEL 4058 PACING LEAD
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DTB
1988-12-15
IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436
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DTB
1988-12-08
PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F
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DTB
1988-12-05
ENDOCARDIAL PACING LEADS-ANCHORING SLEEVE MODIFIED
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DTB
1988-12-05
ENCOR UNIPOLAR VS-1 LEADS
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DTB
1988-10-28
PERMANENT PACING LEAD MODEL RXBJ SERIES
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DTB
1988-10-28
PERMANENT PACING LEADS PYBJ SERIES
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DTB
1988-10-19
CHANGES TO ENCOR PERVENOUS J-ATRIAL LEADS
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DTB
1988-10-14
POLYSAFE(TM) IMPLANTABLE PACING LEAD
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DTB
1988-10-14
MODEL 329-701 BIPOLAR ACTIVE-FIXATION LEAD
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DTB
1988-10-13
MEDTRONIC MODEL 4951P
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DTB
1988-10-06
POLYSAFE IMPLANT. PACING LEADS W/TRABECULOK TIP
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DTB
1988-09-16
POLYSAFE IMPLANT. PACING LEADS W/TINED FIXA. TIP
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DTB
1988-09-06
BIOPORE VS.1 ENDOCARDIAL INTER IMPLANT PACING LEAD
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DTB
1988-09-06
MODEL 5866-34A PACEMAKER LEAD ADAPTOR
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DTB
1988-08-25
MEDTRONIC MODELS 4057/4557 ENDOCARDIAL PACING LEAD
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DTB
1988-06-16
ENCOR BIPOLAR ACT/FIXA LEAD W/POR SUR ELE #329-201
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DTB
1988-05-31
IMPLANTABLE ELECTRODE LEAD, MODEL 030-446
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DTB
1988-05-25
MEDTRONIC MODEL 5866-36 LEAD ADAPTOR KIT
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DTB
1988-05-25
MODEL 435-04 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD
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DTB
1988-05-24
MODEL 438-03 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD
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DTB
1988-03-22
MODEL 438-02 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD
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DTB
1988-03-07
MODEL 439-07 AND 439-09 LIFELINE MYOCARDIAL LEAD
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DTB
1988-02-18
NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR
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DTB
1988-02-12
PERMANENT MYOCARDIAL LEADS MP SERIES
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DTB
1988-02-02
ENDOCARDIAL SCREW-IN LEAD, MODEL 1018T
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DTB
1988-02-02
MEDTRONIC MODEL 4016A ENDOCARDIAL PACING LEAD
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DTB
1988-01-29
ACTIFIX (R) BIPOLAR ENDOCARDIAL SCREW-IN LEAD
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DTB
1988-01-19
MODEL 5013 TRANSVENOUS VENTRICULAR PACING LEAD
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DTB
1988-01-19
PACING LEADS MODEL 3262VU/VB, 3362VU/VB, 3380/3390
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DTB
1988-01-07
POLYFLEX(R) EPICARDIAL 439-04 IMPLANT PACING LEAD
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DTB
1988-01-06
MODEL 366-12 ADAPTAID(TM) STEP-DOWN ADAPTER
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DTB
1987-12-07
MEDTRONIC PERMANENT LEAD INTRODUCER
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DTB
1987-12-03
MODEL 366-30 ADAPTAID(TM) ADAPTER SLEEVE
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DTB
1987-11-06
MEDTRONIC MODEL 5513 ENDOCARDIAL PACING LEAD
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DTB
1987-10-22
MODIFIED MODELS 1025M & 1026T PACING LEAD
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DTB
1987-09-15
PICF 0860/PSCF 0860/PSC 0860/PIAF 0860/PSAF 0860
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DTB
1987-08-18
SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, 030-438
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DTB
1987-05-28
ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG)
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DTB
1987-05-22
IMPLANTABLE PACING LEAD MODELS 487-06 TO 430-01
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DTB
1987-05-21
MODEL 366-12 ADAPTAID (TM) STEP-DOWN ADAPTER
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DTB
1987-05-21
ELECTRODE, PACEMAKER, PERMANENT & TEMPORARY
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DTB
1987-05-21
IMPLANTABLE ELECTRODE LEAD, MODEL 030-439
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DTB
1987-05-06
IMPLANTABLE TINED, TRANS. PACING LEAD/REVIS. LABEL
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DTB
1987-04-10
MODEL 435-03 SIDE HOOK IMPLANTABLE PACING LEAD
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DTB
1987-03-20
ADDITIONAL CARDIAC PACING LEADS #1020 THROUGH 1035
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DTB
1987-03-20
RESUBMISSION OF MODEL 030-437 IMPLANT. ELECTRODE
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DTB
1987-03-03
MODEL PY...U UNIPOLAR & BIPOLAR PACING LEAD
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DTB
1987-01-16
MODEL 366-13 ADAPTAID STEP DOWN ADAPTER
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DTB
1987-01-06
MODEL 5866-24 PACEMAKER LEAD ADAPTOR
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DTB
1987-01-06
MODEL 366-14 INTERMEDICS LEAD CONNECTOR CAP
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DTB
1987-01-06
ANCOR PERVENOUS ACTIVE FIXATION UNIPOLAR LEAD
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DTB
1987-01-06
CCS POLYSAFE(TM) ENDOCARDIAL PACING LEAD
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DTB
1987-01-06
PACE IMPLANT. LEAD/TINED/ATRIAL/J/MODEL 3290
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DTB
1987-01-06
MEDTRONIC MODEL 5013
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DTB
1987-01-06
MODEL 436-01 BIOPORE IMPLANTABLE PACING LEAD
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DTB
1986-12-05
MODEL 486-05 POLYFLEX(R) IMPLANTABLE PACING LEAD
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DTB
1986-12-05
MODEL 366-23 ADAPTAID(TM) STEP-DOWN ADAPTER
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DTB
1986-12-05
TELECTRONICS SREW-IN/SLIM LINE PACING LEADS
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DTB
1986-11-24
DAIG TYPE O4 VS-1 CONNECTOR
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DTB
1986-11-20
MODEL 430-05 POLYFLEX IMPLANTABLE PACING LEAD
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DTB
1986-11-20
MODEL 431-06 POLYFLEX IMPLANTABLE PACING LEAD
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DTB
1986-11-03
MODEL 366-27 ADAPTAID(TM) STEP-DOWN ADAPTER
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DTB
1986-11-03
MODEL 366-28 ADAPTAID(TM) STEP-DOWN ADAPTER
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DTB
1986-11-03
MODEL 493-08 POLYFLEX ENDOCARDIAL LEAD
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DTB
1986-10-31
3.2MM UNIPOLAR & BIPOLAR LEAD CONNECTORS (VS-1)
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DTB
1986-09-23
BIOTRONIK PERMANENT PACEMAKER ELECTRODE
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