Excimer laser intracardiac lead extraction system - PMDA ID 670277_22000BZX00968000_A_02_03
Access comprehensive regulatory information for Excimer laser intracardiac lead extraction system (エキシマレーザ心内リード抜去システム) in the Japan medical device market through Pure Global AI's free bilingual database. This MD medical device is registered under PMDA ID 670277_22000BZX00968000_A_02_03 and manufactured by Philips Japan Co., Ltd.. The device information was last updated on July 04, 2022.
This page provides complete registration details including device class (A0700), classification (Pacemaker/defibrillator lead removal kit / ペースメーカ・除細動器リード抜去キット), 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.
When it is necessary to remove a lead such as an implantable pacemaker or an implantable defibrillator, this product transpires the scar tissue adhering to the area around the lead by laser light from the dedicated excimer laser device 1 () oscillation wavelength 308 nm) and performs lead removal. If a defect or unnecessary lead neglect due to a lead such as an implantable pacemaker or implantable defibrillator is likely to adversely affect the patient's health condition or cause life-threatening problems, it is used to improve these disorders by lead removal. 1) Brand name "excimer laser angiogenesis device" (medical device approval number: 21300BZY00528000) PIP-404_03
本品は、植込み型ペースメーカ、植込み型除細動器等のリードを抜去する必要がある場合、リード周辺に癒着している瘢痕組織を専用のエキシマレーザ装置1（)発振波長308 nm）からのレーザ光により蒸散させ、リード抜去術を施行するために使用する機器である。植込み型ペースメーカ、植込み型除細動器等のリードによる不具合や不必要なリードの放置が、患者の健康状態に悪影響又は生命を脅かす問題をもたらすおそれのある場合、リード抜去によりそれら障害を改善させるために使用する。1) 販売名「エキシマレーザ血管形成装置」（医療機器承認番号：21300BZY00528000）PIP-404_03