GREY:TSTIF - Post by User
Comment by
GoPats1on Jan 24, 2017 1:24pm
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Post# 25747792
RE:Next submission to the FDA ?
RE:Next submission to the FDA ?The company has publicly stated that they will submit in Q1 the ability to sterilize a specific model of a duodenoscope. This, in my opinion, is the most important submission for the company. If approved, they will be the ONLY company given FDA approval to sterilize a duodenoscope, an instrument used in 650,000 procedures that has resulted in several high profile CRE bacterial outbreaks. The company's attorney, when asked his best guess on timing for approval, he thought 6 months post filing. But that was only his best guess.