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  • S&N:根据FDA指示暂停RENASYS负压伤口治疗产品线在美国销售
  • 2014-6-23

  •          根据美国FDA指令,施乐辉公司(伦敦证交所代码SN,NYSE代码SNN)暂停其RENASYS负压伤口治疗产品线在美国销售。施乐辉将遵循FDA指示,对其负压伤口治疗系统作设计改进,以获得新的FDA 510k监管许可。

             Smith & Nephew's Statement regarding RENASYS◊ NPWT in the United States
             http://www.smith-nephew.com/news-and-media/news/statement-regarding-renasys-in-the-us/

             Smith & Nephew (LSE: SN; NYSE: SNN), the global medical technology business, announces that it has temporarily ceased commercial distribution of the RENASYS Negative Pressure Wound Therapy product line in the United States.
             This action follows instruction from the FDA to obtain new regulatory clearances through the premarket notification (510K) process in respect of certain design enhancements made to RENASYS systems. The applications for clearance have now been filed and are awaiting action.