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Alley-oop

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Alley-oop

Re: None

Tuesday, 11/27/2018 5:27:59 PM

Tuesday, November 27, 2018 5:27:59 PM

Post# of 330173
FDA is asking to BILE resubmit the 510(k) form.

Gender-level analysis of the prior ActiPatch clinical data revealed that there indeed were differences in treatment effects between men and women, with women reporting more pain relief than men. The company intends to leverage these findings and resubmit the 510(k) application for a more specific indication:
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