3440c50f-ccad-4adf-bf41-2f40da9aec97UpdatePublished42020-06-192016-09-11In Commercial Distribution07331791010118PrimaryGS1Provox® Vega™17 Fr8112355470923Atos Medical AB1Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voice restoration after surgical removal of the larynx. The prosthesis comes pre-loaded into the SmartInserter, ready for immediate insertion. The SmartInserter is a single-use replacement device intended for anterograde insertion only.falsefalsefalsetruetruetruetruefalsetruetruefalsefalsefalseMR Safetruefalse+4641519800info@atosmedical.comK09045500042533Tracheoesophageal speech valve, indwellingA device designed to be inserted into a surgically-created tracheo-oesophageal fistula after total laryngectomy to provide the patient with voice restoration. It is inserted and replaced on an as needed basis by a speech pathologist or clinician. It has a double flange (one on the outside of the throat and one on the inside) to hold it in place and includes a one-way valve that protects the airway during swallowing and opens under positive pressure so that air crosses into the oesophagus to produce voice (speech rehabilitation). The patient periodically cleans the device in situ. Disposable devices associated with implantation/insertion may be included. This is a single-use device.trueActiveEWLProsthesis, Laryngeal (Taub)LengthSpecial Storage Condition, SpecifyKeep dry. Keep away from sunlight.Handling Environment Temperaturetruefalse