21 CFR 870.3610 — Pacemaker Battery
Cardiovascular (CV) · Part 870 Subpart D—Cardiovascular Prosthetic Devices · § 870.3610
Identification
An implantable pacemaker pulse generator is a device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device is used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders. This device may include triggered, inhibited, and asynchronous modes and is implanted in the human body.
Classification Rationale
Class III (premarket approval).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DSZ | Pacemaker Battery | 3 | 0 | Implant |
| DXY | Implantable Pacemaker Pulse-Generator | 3 | 471 | Implant |
| PNJ | Leadless Pacemaker | 3 | 2 | Implant, Life-Sustaining |
