Ten days ago, the FDA acknowledged having received the application for the extended version of the VP4 . After having done a first survey of conformity with the rules and requirements, it is now ready to take on the analytical part of the study. Starting yesterday, the staff has had to make sure they do not own shares of Tso3 (it's a common procedure).
Last year, it took them barely five weeks to isssue a 510(k) to TSO3.
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