SDL

Transvenous Temporary Phrenic Nerve Stimulator

Product code

SDL

Device name

Transvenous Temporary Phrenic Nerve Stimulator

Device class

Class 3

Medical specialty

Unknown

Marketing pathway

PMA

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).