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Re: ChesapeakePaddler post# 33929

Wednesday, 12/15/2010 10:27:36 AM

Wednesday, December 15, 2010 10:27:36 AM

Post# of 59579
Guys the device needs clinical data...in what form or how that is carried out is the question, It took months to get a radiologist report for which the company paid for and is likely just a simple review with no real guidance form the FDA. I'n sure the agency needs a comphrehesive report with detailed imagery to support all the DVIS claims. It will take at minimum 3-6 months for DEan to get this info. It will take 3-6 months for the FDA to repsond. I woudl say the time frame is 6-13 months before we are facing an answer from the fda.
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