Device Dossier

Surgical procedure kit, ENT, single-use, non-medicated

Device Dossier for Surgical procedure kit, ENT, single-use, non-medicated (Surgical procedure kit, ENT, single-use, non-medicated, Class IIa, sponsor…

Intended purpose

The VORP Sizer Kit contains the VORP Template and the FMT Sizer. Both templates are intended to be used during Vibratory Ossicular Prosthesis implant surgery to support a safe and effective implantation. The VORP template can be used to facilitate positioning of the implant on the skull and creation of the bone bed. The FMT Sizer is intended to be used during surgery to determine the volumetric requirements of the Floating Mass Transducer and assure adequate access for the FMT in the middle ear. The VORP Sizer Kit is delivered sterile and is intended for single use only.

TGA Public Summary