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NeuRx Diaphragm Pacing System

FDA PMAEUDAMED

Class III (US FDA PMA)

PMA P200018

by Synapse Biomedical, Inc.

Identity

Trade Name
NeuRX Diaphragm Pacing System (DPS) FDA PMA
Generic Name
diaphragmatic/phrenic nerve laparoscopically-implanted stimulator FDA PMA

Identifiers

PMA Number
P200018 FDA PMA
FDA Product Code
OIR FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Anesthesiology FDA PMA
FDA Decision
APPR Approved FDA PMA

The NeuRx Diaphragm Pacing System is a diaphragmatic and phrenic nerve laparoscopically-implanted stimulator. It is designed to provide stimulation to the diaphragms of patients who lack control of their own breathing due to high spinal cord injuries.

This device is indicated for use in patients 18 years of age or older who have stimulatable diaphragms. It allows patients to breathe without the assistance of a mechanical ventilator for at least 4 continuous hours per day. The system is authorized under FDA PMA and MDD regulations.

Manufacturer's product page: NeuRx DPS®

Frequently asked questions

Who is the NeuRx Diaphragm Pacing System intended for?

The system is intended for patients 18 years of age or older who have stable, high spinal cord injuries and possess stimulatable diaphragms but lack the ability to control them.

What is the primary function of this device?

The device functions as a diaphragmatic and phrenic nerve stimulator, allowing patients to breathe independently of a mechanical ventilator for a minimum of 4 continuous hours each day.

How is the NeuRx Diaphragm Pacing System implanted?

The system is a laparoscopically-implanted stimulator, meaning it is placed into the body using laparoscopic surgical techniques to interact with the phrenic nerve and diaphragm.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Diaphragm Pacing System Technology, [PDF] Urgent Field Safety Notice - BfArM, NeuRx Diaphragm Pacing System – P200018 - FDA, NeuRx DPS Care and Use Video for model # 23-0021 - YouTube, Diaphragm Pacing System Pioneered at UH and CWRU ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Synapse Biomedical, Inc.

Sources (2)

  • FDA PMA P200018 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026