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血管内特殊球囊审评思考

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文章对血管内应用的压力聚焦型、约束型、药物涂层等特殊球囊的结构特点与临床应用进行了梳理,结合结构特点和风险点分析了各类球囊的性能研究关注点,以期为该类产品的研发、注册提供参考.
Discussion on Registration Evaluation Concerns of Specialty Balloon
The structural characteristics and clinical application of specialty balloon were summarized in this paper.According to structural characteristics and risk,performance study concerns were analyzed to provide reference for the development and registration application of such products.

specialty balloonfocused force balloonchocolate balloondrug-coated balloonperformance study

张向梅、李彦弛、陈易北、董珊

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国家药品监督管理局医疗器械技术审评检查大湾区分中心,广东深圳 518045

特殊球囊 压力聚焦型球囊 约束型球囊 药物涂层球囊 性能研究

2024

中国医疗器械信息
中国医疗器械行业协会

中国医疗器械信息

影响因子:0.375
ISSN:1006-6586
年,卷(期):2024.30(21)