21 CFR 870.3680 — Permanent Pacemaker Electrode
Cardiovascular (CV) · Part 870 Subpart D—Cardiovascular Prosthetic Devices · § 870.3680
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DTB | Permanent Pacemaker Electrode | 3 | 490 | Implant |
| LDF | Electrode, Pacemaker, Temporary | 2 | 129 | Life-Sustaining |
| NHW | Electrode, Pacing And Cardioversion, Temporary, Epicardial | 2 | 2 | Life-Sustaining |
