PNJ · Leadless Pacemaker
Cardiovascular · 21 CFR 870.3610 · Class 3
Overview
| Product Code | PNJ |
|---|---|
| Device Name | Leadless Pacemaker |
| Regulation | 21 CFR 870.3610 |
| Device Class | Class 3 |
| Review Panel | Cardiovascular |
| Implant | Yes |
| Life-Sustaining | 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P150035 | Aveir VR Leadless System | ABBOTT MEDICAL | Mar 31, 2022 | APPR |
| P150033 | MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM | Medtronic, Inc. | Apr 6, 2016 | APPR |
Top Applicants
- ABBOTT MEDICAL — 1 clearance
- Medtronic, Inc. — 1 clearance
