Device Dossier
Prosthesis, internal, valve, speech, tracheostomy
Device Dossier for Prosthesis, internal, valve, speech, tracheostomy (Prosthesis, internal, valve, speech, tracheostomy, Class IIa, sponsor Medtronic).…
- GMDN category: Prosthesis, internal, valve, speech, tracheostomy
Intended purpose
The device is intended for use only with a cuffless or fenestrated tracheostomy tube to provide a means of phonation for alert, awake tracheotomized patients who can breathe spontaneously without assisted mechanical ventilation.