Device Dossier
- - Prosthesis, ossicular
Device Dossier for - - Prosthesis, ossicular (Prosthesis, ossicular, Class IIb, sponsor MED-EL Implant Systems). ARTG record, intended purpose, GMDN…
- GMDN category: Prosthesis, ossicular
Intended purpose
A tympanoplasty prosthesis intended to be used as a partial replacement of the ossicles of the middle ear to restore the mechanical sound transmission from the tympanic membrane to the oval window. The tympanoplasty prosthesis is intended to treat patients of all ages. Tympanoplasty Sizers are intended to be used temporarily during a partial tympanoplasty replacement of the ossicles of the middle ear, to determine the functional length of the needed prosthesis. The tympanoplasty Sizers are single-use surgical instruments for transient use.