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FDA Changes Agenda for Orthopedic Panel


Federal Register Notice: FDA is amending the 11/23 Federal Register notice of a meeting of the Orthopedic and Rehabilitation Devices Panel to change the agenda on page 72972 to read in the first column as follows: The committee will discuss, make recommendations, and vote on information regarding the premarket application (PMA) for the DIAM Spinal Stabilization System, sponsored by Medtronic Sofamor Danek USA. The DIAM Spinal Stabilization System is indicated for skeletally mature patients that have moderate low back pain (with or without radicular pain) with current episode lasting less than 1 year in duration secondary to lumbar degenerative disc disease (DDD) at a single symptomatic level from L2-L5. DDD is confirmed radiologically with one or more of the following factors: (1) Patients must have greater than 2 mm of decreased disc height compared to the adjacent level; (2) scarring/thickening of the ligamentum flavum, annulus fibrosis, or facet joint capsule; or (3) herniated nucleus pulposus. The DIAM device is implanted via a minimally invasive posterior approach. Contact Sara Anderson, Sara.Anderson@fda.hhs.gov, (301) 796-7047. To view this notice, click here.