賽諾醫療(688108.SH):新型藥物洗脫支架系統獲得美國FDA附條件批準
格隆匯7月21日丨賽諾醫療(688108.SH)公佈,公司於2021年12月向美國食品藥品監督管理局(簡稱“FDA”)遞交了公司新型藥物洗脫支架系統的註冊申報資料。公司於近日收到美國FDA通知,公司新型藥物洗脫支架系統PMA申請獲FDA附條件批準,美國FDA將在公司按其要求完成相關針對性完善工作後,爲公司簽發正式批準令。
本次公司新型藥物洗脫支架系統獲得美國FDA附條件批準,是公司冠脈領域的重要里程碑,意味着公司冠脈支架產品已經符合美國FDA的技術審評標準。本次公司新型藥物洗脫支架系統獲美國FDA附條件批準後,公司尚需按美國FDA要求完成相關針對性完善工作後方可獲得FDA簽發的正式批準令並在FDA標準下投入生產以及在美國正式開展該產品的商業化銷售工作。
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