OIR · Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator
· Class 3
Overview
| Product Code | OIR |
|---|---|
| Device Name | Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator |
| Device Class | Class 3 |
| Review Panel | |
| Implant | Yes |
| Life-Sustaining | Yes |
Identification
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P200018 | NeuRX Diaphragm Pacing System (DPS) | Synapse Biomedical, Inc. | Mar 31, 2023 | APPR |
Top Applicants
- Synapse Biomedical, Inc. — 1 clearance
