Product code OIR

Device name

Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

Medical specialty

Unknown

Device class

3

Review panel

AN

Implant

Y

Life sustaining/supporting

Y

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset