Replies to post #5079 on CytoSorbents Corporation (CTSO)

[Plowmaster]

Well if they have to they have to. I just said ideally. I don't know what communications they have had so far with the FDA, but it's entirely possible CBER said class III and PMA. I was simply hoping they could negotiate into a Class II and go the 510(k) route. I know that's what I would push for.