DSZ · Pacemaker Battery
Cardiovascular · 21 CFR 870.3610 · Class 3
Overview
| Product Code | DSZ |
|---|---|
| Device Name | Pacemaker Battery |
| Regulation | 21 CFR 870.3610 |
| Device Class | Class 3 |
| Review Panel | Cardiovascular |
| Implant | Yes |
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).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
