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Boxsterfan

08/01/10 4:24 PM

#21635 RE: BennyJ #21627

Then why did they apply for IDE status on the DVIS?

Why apply for the status of IDE when you have no intent on using it?

Maybe they were using it as a marketing tool? Maybe this pissed off the previous FDA team that they wasted their time?

Makes no sense to apply for IDE unless you are going to use it (or were trying to get some device recognition (marketing) out there.