XIENCE Skypoint 48 Drug Eluting Stent - PMDA ID 381005_30200BZX00330000_A_01_03
Access comprehensive regulatory information for XIENCE Skypoint 48 Drug Eluting Stent (XIENCE Skypoint 48 薬剤溶出ステント) in the Japan medical device market through Pure Global AI's free bilingual database. This MD medical device is registered under PMDA ID 381005_30200BZX00330000_A_01_03 and manufactured by Manufacture and sales / Abbott Medical Japan G.K.. The device information was last updated on September 30, 2022.
This page provides complete registration details including device class (A0700), classification (coronary stent / 冠動脈ステント), 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.
In the event of life-threatening complications, coronary stenting is used to treat patients with symptomatic ischemic heart disease with a new coronary artery lesion (lesion length less than or equal to 44 mm) with a control vessel diameter ranging from 2.5 mm to 4.25 mm, where emergency coronary artery bypass surgery can be performed quickly.
患者の生命に関わる合併症が発生した場合のため、冠動脈ステント留置術は、緊急冠動脈バイパス手術が迅速に行える施対照血管径が2.5 mmから4.25 mmの範囲にあり、新規の冠動脈病変（病変長44 mm以下）を有する症候性虚血性心疾患患者の治療。