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MyoDex Lead - PMDA ID 381005_22400BZX00165000_A_03_06

MyoDex リード

Access comprehensive regulatory information for MyoDex Lead (MyoDex リード) in the Japan medical device market through Pure Global AI's free bilingual database. This MD medical device is registered under PMDA ID 381005_22400BZX00165000_A_03_06 and manufactured by Manufacture and sales / Abbott Medical Japan G.K.. The device information was last updated on December 27, 2021.

This page provides complete registration details including device class (A0700), classification (Implantable defibrillator/pacemaker lead / 植込み型除細動器・ペースメーカリード), 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.

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PMDA Official Data
Bilingual (EN/JP)
MD
A0700
381005_22400BZX00165000_A_03_06
MD
A0700
MyoDex Lead
MyoDex リード
PMDA ID: 381005_22400BZX00165000_A_03_06
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Intended Use / 使用目的
English

This product is used with PG and is intended to continuously stimulate the heart muscle for a long time and correct the heart rhythm.

日本語 (Japanese)

本品は、PGと共に使用し、心筋に長時間連続して刺激を与え、心臓のリズムを補正する事を目的とする。

Device Classification / 分類
Device Type
MD
Device Class
A0700
Class Name (English)
Implantable defibrillator/pacemaker lead
Class Name (日本語)
植込み型除細動器・ペースメーカリード
Registration Information / 登録情報
PMDA ID
381005_22400BZX00165000_A_03_06
Last Update Date
December 27, 2021
Official Documents
Manufacturer / 製造販売業者
日本語 (Japanese)
製造販売/アボットメディカルジャパン合同会社
Product Names / 製品名
Market Name (English)
MyoDex Lead
Market Name (日本語)
MyoDex リード