FYI, it will be a PMA FDA approval, not a 510k. Minimum 3 years, but I would say there will a much tighter guidelines by the FDA on the trials for this one. Signing up willing participants for the trial will be a huge challenge too.
Establishments Labs wont be too keen to spend $10m on trials when their own product is selling well.
Have another read of hottod's post.
And by the way, I like swimming (breast stroke obviously) in the deep end.
Recent Bans of Textured Implants & Polynovo to Stop BIA ALCL?, page-27
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