If you need changes, and after the changes you get SE, then you still got a final determination of SE. That counts. In fact, virtually every single 510(k) application requires changes prior to an SE determination. It is extraordinary for a first submission to be approved without some changes, without some AI request. The analysis is whether you get SE or NSE as your final determination, and 97% of applications get SE as the final determination and 3% get NSE as a final determination. As we have experienced better than most, some applications take longer than others to get there, but all that matters to longs is SE vs. NSE. I'm not a flipper or a trader trying to make $500 on a flip here and there, I'm here for FDA clearance, whenever that comes (and I believe it comes by next week), and I like my chances of getting SE (97%) better than the chances of the fearmongers who predict NSE (3%).
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