At the halfway point of the process, the Company received notice from the FDA that additional information regarding the PMA is required for the continuation of a substantive review. This request, which is not unique to the Breakthrough Device Program, places the application file on hold for approximately 4 to 6 months while the Company addresses the FDA's questions.
any thoughts on what a substantive review would mean?
also what does the context of "not unique" imply?
thanks
Ann: Form 8-K, page-44
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