FDA delays VertiFlex’s Superion Interspinous Spacer System vote meeting

VertiFlex announced that the U.S. Food and Drug Administration has scheduled an Orthopedic and Rehabilitation Devices Advisory Panel meeting on Feb. 20, 2015 to discuss and vote on its premarket approval application for the Superion Interspinous Spacer System.

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The meeting was originally scheduled for Dec. 12 and has been re-scheduled by the FDA because they were unable to complete their internal review of the PMA data in time.

 

The Superion Interspinous Spacer System is a minimally invasive spinal implant designed to treat moderate lumbar spinal stenosis. The device received the CE Mark in 2007 and has been implanted in more than 2,000 patients worldwide.

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