DTB · Permanent Pacemaker Electrode
Cardiovascular · 21 CFR 870.3680 · Class 3
Overview
| Product Code | DTB |
|---|---|
| Device Name | Permanent Pacemaker Electrode |
| Regulation | 21 CFR 870.3680 |
| Device Class | Class 3 |
| Review Panel | Cardiovascular |
| Implant | Yes |
Identification
Temporary pacemaker electrode: A device consisting of flexible insulated electrical conductors with one end connected to an external pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. Permanent pacemaker electrode: A device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.
Classification Rationale
Temporary pacemaker electrode: Class II (performance standards). Permanent pacemaker electrode: Class III (premarket approval).
Recent Cleared Devices (20 of 490)
Showing 20 most recent of 490 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P130012 | MYOPORE SUTURELESS MYOCARDIAL PACING LEAD | Great Batch Medical | Apr 30, 2015 | APPR |
| P120017 | MODEL 5071 LEAD | Medtronic, Inc. | Apr 27, 2015 | APPR |
| K061212 | BIOTRONIK ENDOCARDIAL PACING LEADS | Biotronik, Inc. | Jul 10, 2006 | SESE |
| K041809 | PERMANENT PACING LEAD, MODEL PY2 | Oscor, Inc. | Aug 6, 2004 | SESE |
| K040569 | PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU | Oscor, Inc. | Apr 7, 2004 | SESE |
| K031274 | MODEL 5071 MYOCARDIAL PACING LEAD | Medtronic Vascular | May 22, 2003 | ST |
| K031210 | MODEL 4951M MYOCARDIAL UNIPOLAR LEAD | Metronic, Inc. | May 16, 2003 | SESE |
| K023205 | ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP | Biotronik, Inc. | Apr 24, 2003 | ST |
| K024053 | PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB | Oscor, Inc. | Jan 31, 2003 | SESE |
| K023803 | MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS | Biotronik, Inc. | Dec 11, 2002 | SESE |
| K023099 | AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP | Biotronik, Inc. | Oct 18, 2002 | SESE |
| K021217 | AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP | Biotronik, Inc. | May 1, 2002 | SESE |
| K010281 | MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP | Biotronik, Inc. | Apr 9, 2002 | SESE |
| K020669 | PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB | Oscor, Inc. | Mar 28, 2002 | SESE |
| K013339 | PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS | Oscor, Inc. | Nov 8, 2001 | ST |
| K003918 | OSCOR PERMANENT PACING LEAD RZ MODEL SERIES | Oscor, Inc. | May 22, 2001 | ST |
| K003072 | PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES | Biotronik, Inc. | Jan 9, 2001 | SESE |
| K001413 | ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668 | Biotronik, Inc. | Jun 2, 2000 | ST |
| K994240 | EX 45-BP, MODEL 330 132; EX 53-BP, MODEL 130 018; EX 60-BP, MODEL 330 133 | Biotronik, Inc. | Apr 13, 2000 | ST |
| K993448 | STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS | Ela Medical, Inc. | Apr 10, 2000 | ST |
Top Applicants
- Intermedics, Inc. — 105 clearances
- Medtronic Vascular — 69 clearances
- Telectronics, Inc. — 35 clearances
- Pacesetter Systems — 33 clearances
- Daig Corp. — 28 clearances
