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Re: Rockobongo1281 post# 8560

Wednesday, 04/19/2017 10:23:13 AM

Wednesday, April 19, 2017 10:23:13 AM

Post# of 27409
From the article "A large-scale U.S. randomized, controlled trial called REFRESH (REduction in FREe Hemoglobin) II, intended to support FDA approval of CytoSorb, will start later this year."

I think "Large-scale" is further confirmation of the PMA route rather than 510K.
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