Wright Medical Group, Inc. Announces Agreement With FDA Office Of Device Evaluation To File PMA Amendment For Augment® Bone Graft In Lieu Of Dispute Resolution Panel
Published: Mar 11, 2014
MEMPHIS, Tenn.--(BUSINESS WIRE)--Wright Medical Group, Inc. (NASDAQ: WMGI) today announced it has reached an agreement with the Office of Device Evaluation (ODE) of the U.S. Food and Drug Administration (FDA) under which ODE will accept a further amendment to the Pre-Market Approval application (PMA) for Augment® Bone Graft in lieu of proceeding with the Dispute Resolution Panel (DRP) that was scheduled for the week of May 19, 2014. The agreement with ODE remains subject to final approval by the FDA appeal authority. That approval is expected shortly.
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