

# PSR · Implanted Phrenic Nerve Stimulator For Central Sleep Apnea

_ ·  · Class 3_

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

## Overview

- **Product Code:** PSR
- **Device Name:** Implanted Phrenic Nerve Stimulator For Central Sleep Apnea
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Implant:** yes

## Identification

The device is intended to stimulate the phrenic nerve to produce diaphragm movement during sleep.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P160039](https://fda.innolitics.com/submissions/AN/AN-misc/PSR/P160039.md) | remede® System | Respicardia | Oct 6, 2017 | APPR |

## Top Applicants

- Respicardia — 1 clearance

---

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

**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
