SDL · Transvenous Temporary Phrenic Nerve Stimulator
· Class 3
Overview
| Product Code | SDL |
|---|---|
| Device Name | Transvenous Temporary Phrenic Nerve Stimulator |
| Device Class | Class 3 |
| Review Panel |
Identification
The device is intended to be implanted transvenously to stimulate the phrenic nerves to improve weaning from a mechanical ventilator. The device is temporary (<30 days) and is for use only in patients 18 years of age or older.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P240012 | AeroPace® System | Lungpacer Medical USA, Inc. | Dec 4, 2024 | APPR |
Top Applicants
- Lungpacer Medical USA, Inc. — 1 clearance
