Product code DTB
- Device name
- Permanent Pacemaker Electrode
- Medical specialty
- Cardiovascular
- Device class
- 3
- Regulation number
- 870.3680
- Review panel
- CV
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P120017S040 | Myocardial Pacing Lead | Medtronic, Inc. | 2026-04-15 |
| P120017S039 | Myocardial Pacing Lead | Medtronic, Inc. | 2026-02-20 |
| P120017S038 | Model 5071 Lead | Medtronic, Inc. | 2025-03-20 |
| P120017S037 | Myocardial Pacing Lead | Medtronic, Inc. | 2024-11-13 |
| P120017S036 | Myocardial Pacing Lead | Medtronic, Inc. | 2024-10-17 |
| P130012S016 | Myopore® Sutureless Myocardial Pacing Lead | Great Batch Medical | 2024-04-19 |
| P130012S015 | Myopore Sutureless Myocardial Pacing Lead | Great Batch Medical | 2023-12-13 |
| P120017S035 | Myocardial Pacing Lead | Medtronic, Inc. | 2023-12-13 |
| P120017S034 | Myocardial Pacing Lead | Medtronic, Inc. | 2023-11-03 |
| P120017S033 | Myocardial Pacing Lead | Medtronic, Inc. | 2023-08-01 |
| P130012S014 | Myopore® Sutureless Myocardial Pacing Lead | Great Batch Medical | 2023-07-07 |
| P120017S032 | Myocardial Pacing Lead | Medtronic, Inc. | 2023-06-14 |
| P130012S013 | Myopore® Sutureless Myocardial Pacing Lead | Great Batch Medical | 2023-02-07 |
| P130012S010 | Myopore Sutureless Myocardial Pacing Lead | Great Batch Medical | 2022-12-12 |
| P130012S009 | Myopore® Sutureless Myocardial Pacing Lead | Great Batch Medical | 2022-10-05 |
| P120017S031 | Myocardial Pacing Lead | Medtronic, Inc. | 2022-06-01 |
| P120017S030 | Myocardial Pacing Lead | Medtronic, Inc. | 2022-04-21 |
| P120017S029 | Myocardial Pacing Lead | Medtronic, Inc. | 2021-12-07 |
| P120017S028 | Myocardial Pacing Lead | Medtronic, Inc. | 2021-08-17 |
| P120017S027 | Myocardial Pacing Lead | Medtronic, Inc. | 2021-03-04 |
| P120017S025 | Myocardial Pacing Lead | Medtronic, Inc. | 2020-12-15 |
| P120017S026 | Myocardial Pacing Lead | Medtronic, Inc. | 2020-12-08 |
| P120017S024 | Myocardial Pacing Lead | Medtronic, Inc. | 2020-11-18 |
| P120017S023 | Myocardial Pacing Lead | Medtronic, Inc. | 2020-08-06 |
| P120017S022 | Myocardial Pacing Lead | Medtronic, Inc. | 2020-07-22 |
| P120017S021 | Myocardial Pacing Lead | Medtronic, Inc. | 2020-06-02 |
| P120017S020 | Myocardial Pacing Lead | Medtronic, Inc. | 2019-12-03 |
| P120017S019 | Myocardial Pacing Lead | Medtronic, Inc. | 2019-09-27 |
| P130012S007 | Myopore Sutureless Myocardial Pacing Lead | Great Batch Medical | 2019-07-15 |
| P130012S008 | Myopore Sutureless Myocardial Pacing Lead | Great Batch Medical | 2019-07-03 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K061212 | BIOTRONIK ENDOCARDIAL PACING LEADS | Biotronik, Inc. | 2006-07-10 |
| K041809 | PERMANENT PACING LEAD, MODEL PY2 | Oscor, Inc. | 2004-08-06 |
| K040569 | PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU | Oscor, Inc. | 2004-04-07 |
| K031274 | MODEL 5071 MYOCARDIAL PACING LEAD | Medtronic Vascular | 2003-05-22 |
| K031210 | MODEL 4951M MYOCARDIAL UNIPOLAR LEAD | Metronic, Inc. | 2003-05-16 |
| K023205 | ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP | Biotronik, Inc. | 2003-04-24 |
| K024053 | PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB | Oscor, Inc. | 2003-01-31 |
| K023803 | MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS | Biotronik, Inc. | 2002-12-11 |
| K023099 | AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP | Biotronik, Inc. | 2002-10-18 |
| K021217 | AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP | Biotronik, Inc. | 2002-05-01 |
| K010281 | MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP | Biotronik, Inc. | 2002-04-09 |
| K020669 | PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB | Oscor, Inc. | 2002-03-28 |
| K013339 | PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS | Oscor, Inc. | 2001-11-08 |
| K003918 | OSCOR PERMANENT PACING LEAD RZ MODEL SERIES | Oscor, Inc. | 2001-05-22 |
| K003072 | PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES | Biotronik, Inc. | 2001-01-09 |
| K001413 | ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668 | Biotronik, Inc. | 2000-06-02 |
| K994240 | EX 45-BP, MODEL 330 132; EX 53-BP, MODEL 130 018; EX 60-BP, MODEL 330 133 | Biotronik, Inc. | 2000-04-13 |
| K993448 | STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS | Ela Medical, Inc. | 2000-04-10 |
| K000763 | PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051 | Biotronik, GmbH & Co. | 2000-04-06 |
| K000029 | STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS | Ela Medical, Inc. | 2000-04-04 |
| K993139 | YP 45/15-BP; YP 53/15-BP; YP 60/15-BP | Biotronik, Inc. | 1999-12-17 |
| K990142 | HT, MODEL HT PB | Sulzer Oscor, Inc. | 1999-07-30 |
| K991169 | SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854 | Biotronik, Inc. | 1999-07-01 |
| K990483 | RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777 | Biotronik, Inc. | 1999-06-03 |
| K980869 | SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120 444, 119 684, 120 438 AND 120 143 | Biotronik, Inc. | 1998-09-10 |
| K981083 | 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 | Biotronik, Inc. | 1998-07-22 |
| K972500 | TIR/TIJ AND POLYROX | Biotronik, Inc. | 1998-03-04 |
| K972814 | LOCATOR MODEL 4036 | Pacesetter, Inc. | 1998-02-23 |
| K965106 | ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606 | Biotronik, Inc. | 1998-01-27 |
| K972574 | STELA MODEL UJ45 PACING LEADS | Ela Medical, Inc. | 1998-01-08 |
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| 00613994740922 | Sprint Quattro Secure® DXAC/DSP | MEDTRONIC, INC. | 2014-09-23 |
| 00613994740908 | Sprint Quattro Secure® DXAC/DSP | MEDTRONIC, INC. | 2014-09-23 |
| 00613994719133 | Attain Ability® Plus | MEDTRONIC, INC. | 2014-09-23 |
| 00613994719096 | Attain Ability® Straight | MEDTRONIC, INC. | 2014-09-23 |
| 00613994718853 | Sprint Quattro Secure S® | MEDTRONIC, INC. | 2014-09-23 |
| 00613994718839 | Sprint Quattro Secure S® | MEDTRONIC, INC. | 2014-09-23 |
| 00613994657374 | CapSureFix MRI™ SureScan™ | MEDTRONIC, INC. | 2014-09-23 |
| 00613994657367 | CapSureFix MRI™ SureScan™ | MEDTRONIC, INC. | 2014-09-23 |
| 00613994657350 | CapSureFix MRI™ SureScan™ | MEDTRONIC, INC. | 2014-09-23 |
| 00613994501813 | Capsure® EPI | MEDTRONIC, INC. | 2014-09-23 |
| 00613994501745 | Capsure® EPI | MEDTRONIC, INC. | 2014-09-23 |
| 00613994501721 | Capsure® EPI | MEDTRONIC, INC. | 2014-09-23 |
| 00613994501011 | NA | MEDTRONIC, INC. | 2014-09-23 |
| 00613994492432 | Transvene®-CS/SVC | MEDTRONIC, INC. | 2014-09-23 |
| 00613994119957 | SelectSecure™ | MEDTRONIC, INC. | 2014-09-23 |
| 00613994492364 | Transvene®-CS/SVC | MEDTRONIC, INC. | 2014-09-23 |
| 00613994492340 | Capsure® EPI | MEDTRONIC, INC. | 2014-09-23 |
| 00613994492272 | Capsure® EPI | MEDTRONIC, INC. | 2014-09-23 |
| 00613994469724 | Attain Ability® | MEDTRONIC, INC. | 2014-09-23 |
| 00613994446350 | Sprint Quattro Secure S™ | MEDTRONIC, INC. | 2014-09-23 |
| 00613994446114 | Sprint Quattro Secure S™ DXAC/DSP | MEDTRONIC, INC. | 2014-09-23 |
| 00613994446107 | Sprint Quattro Secure S™ DXAC/DSP | MEDTRONIC, INC. | 2014-09-23 |
| 00613994446091 | Sprint Quattro Secure S™ DXAC/DSP | MEDTRONIC, INC. | 2014-09-23 |
| 00613994446084 | Sprint Quattro Secure S™ DXAC/DSP | MEDTRONIC, INC. | 2014-09-23 |
| 00613994329400 | Capsurefix® Novus | MEDTRONIC, INC. | 2014-09-23 |
| 00613994308658 | Attain® Bipolar OTW | MEDTRONIC, INC. | 2014-09-23 |
| 00613994250223 | Capsure®SP Novus | MEDTRONIC, INC. | 2014-09-23 |
| 00613994250148 | Capsure® VDD-2 | MEDTRONIC, INC. | 2014-09-23 |
| 00613994249951 | Sprint Quattro® | MEDTRONIC, INC. | 2014-09-23 |