FDA product code PNJ: Leadless Pacemaker
PNJ is the FDA product code for leadless pacemaker. It is a Class III device, regulated under 21 CFR 870.3610 and reviewed by the Cardiovascular panel. Devices under PNJ reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 6 recalls for PNJ devices, 4 initiated in the last five years.
Definition
To treat bradycardia (slow heartbeats) with right atrial and/or right ventricular pacing therapy as necessary.
Classification
| Field | Value |
|---|---|
| Device name | Leadless Pacemaker |
| Device class | Class III |
| Regulation | 21 CFR 870.3610 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | PMA |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Recalls for PNJ devices
6 product recalls in 5 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2026-05-12.
| Year | Recalls |
|---|---|
| 2019 | 2 |
| 2024 | 2 |
| 2025 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code PNJ?
PNJ is the FDA product code for leadless pacemaker. It is a Class III device, regulated under 21 CFR 870.3610 and reviewed by the Cardiovascular panel.
What device class is PNJ?
Class III, regulation 21 CFR 870.3610. Typical premarket route: PMA.
Have PNJ devices been recalled?
Yes: 6 product recalls across 5 recall events; the most recent began 2026-05-12.
Next steps
- Run an FDA pathway report with predicate devices for product code PNJ
- Run a recall and safety report across every PNJ manufacturer
- Watch product code PNJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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