Navitor transcatheter valve system - PMDA ID 381005_30400BZX00006000_A_01_02
Access comprehensive regulatory information for Navitor transcatheter valve system (Navitor経カテーテル生体弁システム) in the Japan medical device market through Pure Global AI's free bilingual database. This MD medical device is registered under PMDA ID 381005_30400BZX00006000_A_01_02 and manufactured by Manufacture and sales / Abbott Medical Japan G.K.. The device information was last updated on October 03, 2022.
This page provides complete registration details including device class (A0700), classification (Transcatheter bovine pericardial valve / 経カテーテルウシ心のう膜弁), manufacturer information (English and Japanese), intended use, and regulatory compliance data from the official Japan PMDA medical device database. Pure Global AI offers free bilingual access to Japan's complete medical device registry, helping global MedTech companies navigate PMDA regulations efficiently.
This product is a self-expanding percutaneous aortic biological valve (bovine epicardial valve) system used for percutaneous cardiac valve placement, and is intended for use in patients who have symptomatic severe aortic stenosis caused by sclerosis degeneration of the autologous aortic valve apex and cannot perform surgical surgery and are judged to be best for the patient. However, chronic dialysis patients are excluded.
本品は、経皮的心臓弁留置に用いる自己拡張型の経皮的大動脈生体弁（ウシ心のう膜弁）システムであり、自己大動脈弁弁尖の硬化変性に起因する症候性の重度大動脈弁狭窄を有し、かつ外科的手術を施行することができず、本品による治療が当該患者にとって最善であると判断された患者に使用することを目的とする。ただし、慢性透析患者を除く。