Decision time for FDA on FzioMed’s Oxiplex anti-adhesive spine gel

FzioMed Announces Date for Medical Device Dispute Resolution Panel on Oxiplex® (press release)

FzioMed, Inc., a medical device manufacturer specializing in biomaterials, has received notification from FDA that the Medical Device Dispute Resolution Panel (MDDRP) will convene and make a decision on the approvability of Oxiplex Gel on June 10, 2014.
Oxiplex is an absorbable, clear, viscoelastic hydrogel that is applied during lumbar spine surgery. Oxiplex has been approved for sale in the European Union since 2002 and is now approved in 70 countries. It has been used in more than 350,000 surgeri...