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Panel to Discuss Superion InterSpinous Spacer

02/17/2015

Federal Register Notice: FDA’s Orthopedic and Rehabilitation Panel of the Medical Devices Advisory Committee will meet 2/20, from 8 a.m. to 6 p.m. at the Hilton/Washington DC North, 620 Perry Pkwy., Gaithersburg, MD. The committee will vote on a Vertiflex Inc. PMA for the Superion InterSpinous Spacer device to treat skeletally mature patients suffering from pain, numbness, and/or cramping in the legs (neurogenic intermittent claudication) secondary to a diagnosis of moderate lumbar spinal stenosis, with or without grade 1 spondylolisthesis, confirmed by x-ray, magnetic resonance imaging, and/or computed tomography evidence of thickened ligamentum flavum, narrowed lateral recess, and/or central canal or foraminal narrowing. The Superion ISS is indicated for those patients with impaired physical function who experience relief in flexion from symptoms of leg/buttock/groin pain, numbness, and/or cramping, with or without back pain. The meeting was originally scheduled for 12/12. Contact Anne Marie Williams at Annmarie.Williams@fda.hhs.gov or (301) 796-5966. To view this notice, click here.

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