# NVY · Permanent Defibrillator Electrodes

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/CV-misc/NVY

## Overview

- **Product Code:** NVY
- **Device Name:** Permanent Defibrillator Electrodes
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Implant:** yes
- **Life-sustaining:** yes

## Identification

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.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P240036](https://fda.innolitics.com/submissions/CV/CV-misc/NVY/P240036.md) | OmniaSecure™ MRI SureScan™ Lead Model 3930M | Medtronic, Inc. | Apr 22, 2025 | APPR |
| [P920015](https://fda.innolitics.com/submissions/CV/CV-misc/NVY/P920015.md) | MEDTRONIC(R) TRANSVENE LEAD SYSTEM | Medtronic, Inc. | Dec 9, 1993 | APPR |

## Top Applicants

- Medtronic, Inc. — 2 clearances

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**Source:** [https://fda.innolitics.com/submissions/CV/CV-misc/NVY](https://fda.innolitics.com/submissions/CV/CV-misc/NVY)

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