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BioMimetic Amends Augment Bone Graft PMA, Expects Approval By 2014

BioMimetic Therapeutics submits PMA amendment for its Augment bone graft device to address questions raised by FDA in a “not approvable” letter disclosed in January.

BioMimetic Therapeutics Inc. anticipates FDA approval between April 2013 and January 2014 for its Augment bone graft following submission in late June of a PMA amendment responding to questions raised by the agency.

The anticipated timeline assumes FDA will take six months to review the PMA amendment, “and that they have a second round of questions,” BioMimetic announced July 9.

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