OIR

Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

Product code

OIR

Device name

Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

Device class

Class 3

Medical specialty

Unknown

Marketing pathway

PMA

Flag

Implant

Flag

Life-sustaining / life-supporting

FDA classification definition

The device is intended for use in patients with stable, high spinal cord injuries with stimulatable diaphragms, but who lack control of their diaphragms. The device is indicated to allow the patients to breathe without the assistance of a mechanical ventilator for at least 4 continuous hours a day. For use only in patients 18 years of age or older.

Definition text from the FDA device classification database (U.S. federal government work, public domain).