OIR · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
OIR
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
AN
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
Y
Implant
Y
Third-party review
N
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.