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心瑋醫療-B(06609.HK):SUPSELEK微導管獲FDA授予許可
格隆匯 02-24 16:35

格隆匯2月24日丨心瑋醫療-B(06609.HK)宣佈,美利堅合眾國食品藥品監督管理局("FDA")最近根據《食品、藥品及化粧品法案》(Food, Drugand Cosmetic Act)對公司的SupSelek微導管授予510k許可。

截至公吿日期,公司已取得FDA對SupSelek微導管及Fullblock封堵球囊導管兩款產品授予510k許可。公司將繼續於海外為其產品申請許可及註冊。

公司無法保證最終將能成功把SupSelek微導管或Fullblock封堵球囊導管市場推廣及╱或商業化。

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