Intellis (Conditional MRI Compatible) - PMDA ID 530366_22900BZX00255000_A_01_02
Access comprehensive regulatory information for Intellis (Conditional MRI Compatible) (インテリス(条件付MRI対応)) in the Japan medical device market through Pure Global AI's free bilingual database. This MD medical device is registered under PMDA ID 530366_22900BZX00255000_A_01_02 and manufactured by Medtronic Japan Co., Ltd.. The device information was last updated on September 01, 2022.
This page provides complete registration details including device class (A1200), classification (Implantable pain relief stimulator / 植込み型疼痛緩和用スティミュレータ), 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 used for the purpose of applying electrical stimulation to the epidural space of the spinal cord to relieve chronic intractable pain associated with various diseases. The target pain is chronic intractable pain of the trunk and limbs for which sufficient analgesia or pain relief effect cannot be obtained by drug therapy, nerve block, etc. This product is a device that can perform MRI examination on a limited basis only when the imaging conditions are met. [Precautions related to the intended use or effect] Patient selection Selecting patients whose pain is due to physical causes. Also, the patient must meet the appropriate conditions for performing the surgical procedure.
本品は脊髄硬膜外腔に電気刺激を与え、各種疾患に伴う慢性難治性疼痛を緩和することを目的として使用する。対象となる疼痛は薬物療法、神経ブロック等によって十分な鎮痛又は除痛効果が得られない、体幹及び四肢の慢性難治性疼痛である。なお、本品は撮像可能条件に適合する場合にのみ限定的にMRI検査が可能となる機器である。[使用目的又は効果に関連する使用上の注意]患者の選択疼痛が身体的原因による患者を選択すること。また、患者は外科的手術を施すのに適切な条件を満たしていること。