Device Dossier
Medgyn MTA Thermal Ablation System - Electrosurgical system, general-purpose
Device Dossier for Medgyn MTA Thermal Ablation System - Electrosurgical system, general-purpose (Electrosurgical system, general-purpose, Class IIb,…
- GMDN category: Electrosurgical system, general-purpose
Intended purpose
A thermal ablation system intended for the destruction of abnormal human tissue with high temperatures by tissue contact with an electrically gold alloy tip. It is a battery operated, electronic device used to destroy abnormal cells on the cervix using heat. The probe of the device is inserted into the vaginal canal so that the tip of the device is in contact with the external orifice of the cervix. It is designed to perform low-power destruction of the human cervical tissue with high temperature by tissue contact with an electrically heated tip. The heat generated from the tip destroys abnormal tissue at temperatures within the range of 100°C to 120°C.