# SDL · Transvenous Temporary Phrenic Nerve Stimulator

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/AN-misc/SDL

## Overview

- **Product Code:** SDL
- **Device Name:** Transvenous Temporary Phrenic Nerve Stimulator
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Identification

The device is intended to be implanted transvenously to stimulate the phrenic nerves to improve weaning from a mechanical ventilator. The device is temporary (<30 days) and is for use only in patients 18 years of age or older.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P240012](https://fda.innolitics.com/submissions/AN/AN-misc/SDL/P240012.md) | AeroPace® System | Lungpacer Medical USA, Inc. | Dec 4, 2024 | APPR |

## Top Applicants

- Lungpacer Medical USA, Inc. — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com