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Corin Presentation to FDA Approvals Panel

Ever wonder what they tell the panel to get a 510K approval…

Download presentation here (all 95 pages)

Did you ever wonder how they dealt with the issue of Cobalt Chrome metallosis:
  • Two year study – “nothing of significance to report”
  • This slide below seems to be the in-depth analysis presented and one might be forgiven for thinking, was accepted… well they 510k was approved this earlier 2011…
  • pretty detailed huh…?
  • last two bullet points – really … ?

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