FDA product code NVY: Permanent Defibrillator Electrodes

NVY is the FDA product code for permanent defibrillator electrodes. It is a Class III device, reviewed by the Cardiovascular panel. Devices under NVY reach the market by PMA; FDA lists no cleared 510(k)s for it. 19 PMA applications cite this product code. FDA has posted 5 recalls for NVY devices, 5 initiated in the last five years.

Definition

Permanent defibrillator electrodes are used with compatible implantable cardioverter defibrillators (ICD) and cardiac rhythm therapy-defibrillators (CRT-D) to sense the cardiac rhythm and to deliver high energy therapy to the heart when tachycardia is detected. Some transvenous models can also be used for pacing the right ventricle.

Classification

Recalls for NVY devices

5 product recalls in 3 recall events; 5 initiated in the last five years and 4 still open. Most recent: 2025-07-24.

Frequently asked questions

What is FDA product code NVY?

NVY is the FDA product code for permanent defibrillator electrodes. It is a Class III device, reviewed by the Cardiovascular panel.

What device class is NVY?

Class III. Typical premarket route: PMA.

Have NVY devices been recalled?

Yes: 5 product recalls across 3 recall events; the most recent began 2025-07-24.

Next steps

• Run an FDA pathway report with predicate devices for product code NVY
• Run a recall and safety report across every NVY manufacturer
• Watch product code NVY 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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