SDL — Transvenous Temporary Phrenic Nerve Stimulator Class III
FDA product code SDL covers "Transvenous Temporary Phrenic Nerve Stimulator", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- SDL
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Unknown
- Implant
- No
Definition
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.