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66Mustang

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66Mustang

Re: DRG1025 post# 49872

Monday, 02/06/2017 10:50:54 AM

Monday, February 06, 2017 10:50:54 AM

Post# of 140510
My understanding is an instrument of that level of complexity and risk category takes at least 6 to 9 months from FDA filing to approval. If it's that close to design freeze, they still need to do things like animal and cadaver studies to collect enough data for an analysis to be statistically significant (probably to at least a 95% confidence interval)... If they can hit the market in 2018, it won't be first quarter!
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