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mikepgator

08/12/25 9:31 AM

#191557 RE: mikepgator #191556

Just to clarify, tomorrow is the absolute latest, assuming they submitted the IDE on the same day they released the PR.
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LeAcc

08/12/25 9:37 AM

#191558 RE: mikepgator #191556

I agree that it has. The 30 day clock starts on the date of receipt of submission (announced 14th) as per the FDA website. That would be today.