Diaphragmatic Pacemaker Phrenic Nerve Stimulator

Generic Name

implanted diaphragmatic/phrenic nerve Stimulator

PMA Number

P860026 ↗

FDA Product Code

GZE

Device Class

Class III

Regulation

21 CFR Part 882.5830

Advisory Committee

Anesthesiology

FDA Decision

APPR Approved

• Avery Breathing Pacemaker System NeurostimulatorTransmitter Digital

  Class III

  GUDID on market

• Avery Breathing Pacemaker System Neurostimulator Receiver Implant

  Class III

  GUDID on market

• Avery Breathing Pacemaker System External Antenna

  Class III

  GUDID on market

• Avery Breathing Pacemaker System Neurostimulator Electrode Implant

  Class III

  GUDID on market

• Avery Breathing Pacemaker System Neurostimulator Transmitter

  Class III

  GUDID on market

• Spinal Epidural Electrode for P.E.N.S. Model E-355

  Class III

  FDA PMA P810033 Withdrawn Approved 2 Feb 1982

See all devices from Avery Biomedical Devices, Inc. →

• What is the primary purpose of the Diaphragmatic Pacemaker Phrenic Nerve Stimulator, and who would benefit from it?

  The Diaphragmatic Pacemaker Phrenic Nerve Stimulator is designed to electrically stimulate the phrenic nerve, triggering diaphragmatic contraction to assist or replace respiratory function. It is intended for patients with neuromuscular disorders or spinal cord injuries who experience impaired breathing due to weakened or non-functional diaphragm muscles. This device helps restore breathing mechanics when traditional ventilation methods are insufficient or impractical.

• How is this device regulated, and what approval process does it undergo?

  This device is classified as a Class III medical device under FDA regulation 882.5830 and requires **FDA Premarket Approval (PMA)**. The approval process includes a thorough review by the FDA’s Anesthesiology (AN) Advisory Committee, as indicated by the product code **GZE**. The device holds PMA number **P860026**, meaning it has undergone rigorous clinical evaluation to ensure safety and effectiveness before being authorized for use in the U.S.

• Is this device intended for single-use or can it be reused across multiple patients?

  The Diaphragmatic Pacemaker Phrenic Nerve Stimulator is explicitly designed for **single-patient use**. While the data does not specify reuse restrictions, the nature of an implanted device—where it is surgically placed within a patient—strongly implies it is not intended for reuse. Reuse would pose significant risks, including infection and device malfunction, so it should only be used once per patient.

• What medical specialties are primarily involved in the use of this device, and why?

  The device falls under the **Neurology** medical specialty, as indicated in the OpenFDA data, though it is also reviewed by the Anesthesiology Advisory Committee. This is because the primary condition it addresses—neuromuscular disorders or spinal cord injuries—falls within neurology, while its implantation and postoperative management may involve anesthesiology or critical care specialists. Clinicians in these fields would collaborate to ensure proper patient selection, surgical placement, and long-term respiratory support.