Device Dossier
Prosthesis, internal, valve, speech, tracheostomy
Device Dossier for Prosthesis, internal, valve, speech, tracheostomy (Prosthesis, internal, valve, speech, tracheostomy, Class IIa, sponsor Main…
- GMDN category: Prosthesis, internal, valve, speech, tracheostomy
Intended purpose
Used to provide an air shunt from the trachea to the esophagus for laryngectomy patients. Commonly called a voice prosthesis, the shunt has a flapper valve which stops secretions from entering the trachea while allowing air to move from the trachea to the esophagus to produce voice.