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.