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MiMedx Group, Inc. Message Board

  • tipsmaster tipsmaster Sep 10, 2013 4:54 PM Flag

    SHORTS let me spell it out to you

    "We sent our response to the FDA on Friday, and while the FDA’s “Untitled Letter” was not specific about what exactly is at issue, we tried to cover all the factors we could imagine with our response. Frankly, we do not see how there can be an issue. The micronization process we use for our allografts is the same basic process that is used by dozens of other suppliers of micronized human tissue, such as dermis and bone; we employ the same techniques that have been used by others for a decade. We have requested a meeting with the FDA immediately in order to bring this matter to quick closure. Please recall that this “Untitled Letter” is not a warning letter or anything that rises to that level. It does not affect our sheet allografts, only our micronized product"

 
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