California-based FzioMed lands a Dispute Resolution Panel date with FDA regulators to discuss the Oxiplex spinal surgery gel that the agency denied in 2008.
Once-scorned biomaterials maker FzioMed is getting another day with the FDA to discuss its Oxiplex spinal surgery gel, which was rejected by U.S. healthcare officials in 2008.
FzioMed will meet June 10, 2014, with the FDA's Medical Device Dispute Resolution Panel to discuss the "approvability" of the Oxiplex gel, which has been on the European market since 2012 and is approved for sale in 70 countries. The product has already been used in more than 350,000 surgeries, FzioMed said.
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