I didn’t expect that,Normally if fda wants to review they do it in 45-60days but obviously they didn’t and by 90-100days if there is no question about reviewing then it’s good to go for approval but in this case they asked questions when the approval was due,so obviously fda wants them to do something to improve the device and this exactly what happens in 2018 about their last 510k application as well and they end up withdrawing the 510k application,Not a good sign so,I am out DYOR
Ann: FDA Strategy and Regulatory Update, page-34
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