FDA
22nd September 2014

Meeting Announcement – Superion InterSpinous Spacer

December 12, 2014 8:00 a.m. to 6:00 p.m.: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement.

Meeting Announcement – Superion InterSpinous Spacer

December 12, 2014 8:00 a.m. to 6:00 p.m.: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement

Holiday Inn Washington-College ParkWhere:

10000 Baltimore Ave.
College Park, MD 20740
1-800-315-2621

On December 12, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Superion InterSpinous Spacer device sponsored by Vertiflex Incorporated.  The proposed Indication for Use for the Superion InterSpinous Spacer device, as stated in the PMA, is as follows:  the Superion InterSpinous Spacer (the Superion ISS) is intended 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, MRI and/or CT 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 Superion ISS may be implanted at one or two adjacent lumbar (L) levels in patients in whom treatment is indicated at no more than two levels, from L1 to L5.

Please click HERE for the current roster of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee.

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