FDA product code NVZ: Pulse Generator, Permanent, Implantable
NVZ is the FDA product code for pulse generator, permanent, implantable. It is a Class III device, reviewed by the Cardiovascular panel. Devices under NVZ reach the market by PMA; FDA lists no cleared 510(k)s for it. 16 PMA applications cite this product code. FDA has posted 40 recalls for NVZ devices, 7 initiated in the last five years.
Definition
Intended as a permanent implant to deliver pacing pulses and other pacing therapies through pacing leads implanted in the heart.
Classification
| Field | Value |
|---|---|
| Device name | Pulse Generator, Permanent, Implantable |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Recalls for NVZ devices
40 product recalls in 19 recall events; 7 initiated in the last five years and 23 still open. Most recent: 2025-06-18.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2019 | 7 |
| 2020 | 9 |
| 2021 | 3 |
| 2024 | 3 |
| 2025 | 3 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- C1767 — Generator, neurostimulator (implantable), non-rechargeable
- C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system
- C7538 — Insertion of new or replacement of permanent pacemaker with ventricular transvenous electrode(s), with insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of implantable defibrillator or pacemaker pulse generator (e.g., for upgrade to dual chamber system)
- C7540 — Removal of permanent pacemaker pulse generator with replacement of pacemaker pulse generator, dual lead system, with insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of implantable defibrillator or pacemaker pulse generator (eg, for upgrade to dual chamber system)
- C7539 — Insertion of new or replacement of permanent pacemaker with atrial and ventricular transvenous electrode(s), with insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of implantable defibrillator or pacemaker pulse generator (eg, for upgrade to dual chamber system)
Frequently asked questions
What is FDA product code NVZ?
NVZ is the FDA product code for pulse generator, permanent, implantable. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is NVZ?
Class III. Typical premarket route: PMA.
Have NVZ devices been recalled?
Yes: 40 product recalls across 19 recall events; the most recent began 2025-06-18.
Next steps
- Run an FDA pathway report with predicate devices for product code NVZ
- Run a recall and safety report across every NVZ manufacturer
- Watch product code NVZ 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.