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Panel to Discuss Visioncare PMA

03/24/2008

Federal Register Notice: FDA will hold a meeting of the Ophthalmic Devices Panel of the Medical Devices 4/24-25, from 8:30 a.m. to 5 p.m. at the Gaithersburg Holiday Inn, Ballroom, 2 Montgomery Village Ave., Gaithersburg, MD. On 4/24, the committee will discuss, make recommendations, and vote on a Visioncare Technologies PMA for an implantable miniature telescope, a visual prosthetic device, indicated for monocular implant in patients with stable, moderate to profound central vision impairment due to bilateral central scotomas associated with end-stage macular degeneration with geographic atrophy or disciform scar, foveal involvement, and cataract. On 4/25, the committee will discuss general issues about the post market experience with phakic intraocular lenses and laser-assisted in situ keratomileusis (LASIK). Contact Karen F. Warburton, 240-276-4238. To view this notice, click here.

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