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Re: Admiral38 post# 30100

Wednesday, 10/27/2010 8:27:09 AM

Wednesday, October 27, 2010 8:27:09 AM

Post# of 59551
Point well taken, however at this time I sense that clearance is imminent. According to the company,"no new questions". So we don't have to worry about a "secret" completely new re-submission like we had earlier this year {to be divulged at a later time}. I believe that approval would have to be in the very final stages, even as lethargic as the government is. It ONLY appears as though the FDA has overstepped their bounds with regard to function vs. safety of the device, and radiation is easily determined. The real issue is with imagery because; if you were under the surgeon's knife that was being guided by the Dvis, {THAT} is where by the highest concern FOR SAFETY is in my estimation. This is why the radiologist review and scrutiny. Would Dean {or any FDA reviewer} be willing to be operated on with the Dvis as the sole means of guidance support for the sugeon? THAT is the question. It would be nice to hear some confirmation of that question from Dean, thanks.