OIR — Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator Class III
FDA product code OIR covers "Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator", a Class III medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants.
Classification Details
- Product Code
- OIR
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Unknown
- Implant
- Yes
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.