Device Dossier
Prosthesis, ossicular
Device Dossier for Prosthesis, ossicular (Prosthesis, ossicular, Class IIb, sponsor MED-EL Implant Systems). ARTG record, intended purpose, GMDN category…
- GMDN category: Prosthesis, ossicular
Intended purpose
A stapesplasty or tympanoplasty prosthesis intended to be used as a replacement of the ossicles of the middle ear. This passive implant restores the mechanical sound transmission from the tympanic membrane to the oval window. The prosthesis is intended to treat patients of all ages.