Agreed, there are significant gaps in 90-day expectations and what is being presented as the reason why no decision available within the 90 day period.
Encourage others to inquire with company about status of 510k and specifically what is the submission number?
Can share what response I received from company PR manager:
??> "Can you share the 510k number being referenced?" AA> "The company has asked not to."
It does not say exactly that he was talking about the 510k first off- but Actipatch info...you could also say that BIEL requested "info" about Actipatch regarding the regulatory status info regarding the final order "earlier this year" (he didn't say August when the 510k was submitted though it is implied - it could have been sooner) but at least we know it was this year....because he then mentions the 510k right after.
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