Transvenous Temporary Phrenic Nerve Stimulator
A transvenous temporary phrenic nerve stimulator is a Class III device (PMA required) that is transiently implanted transvenously to stimulate the phrenic nerves, improving weaning from mechanical ventilation in adult patients (18 years or older); the device is temporary, intended for use less than 30 days. As a Class III device without an assigned regulation number, it required Premarket Approval, reflecting the high risk of its novel intravascular nerve stimulation mechanism. The product code is SDL, reviewed by the Anesthesiology panel; the device is not flagged as an implant per the record and does not support life-sustaining functions per the record.
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Basic Information
- Product Code
- SDL
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- AN
- Submission Type
- 2
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.