It's exempt, so no approval is required. I think they were expecting to have some dialog and get the approval stamp. Rules changed just this year. They'll need approval for the surgical internal though and all of the data they have to date, including the animal studies this year can be applied to it. They did state that they would take the gel to market so they should be getting that team together to make it happen by mid 2018. Next is getting the CE mark.
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