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randvrutledge

04/30/10 5:28 PM

#14505 RE: docmts2 #14504

I don't, I just remember him mentioning on a CC that he had decided to remove the mamogram function of the DVIS from the 510K because the team was really taking a long time on that particular function. Dean said that even after he removed that part they continued on about it for another six months or so. That is obviously not verbatim, I'm just trying to remember the basics of what was said.

Dean said he is trying his best to get this approved as soon as possible, and felt that by removing the mamogram portion now, he could get approval more quickly, and then it would be easier after initial approval to go back and add it later.