Second sight lands FDA panel date for retinal prosthesis HDE

Thu, 07/19/2012 - 12:56pm
Mass Device

The FDA's ophthalmic device panel in September will review a humanitarian device exemption application for Second Sight Medical Products' Argus II retinal prosthesis.

Argus II

Second Sight Medical Products, the world's only developer and manufacturer of an approved retinal prosthesis for the blind, won a date with the FDA to consider humanitarian device exemption status for its Argus II system.

On Sept. 28, 2012, the FDA's ophthalmic devices panel will review the application for the Argus II device for patients aged 25 and older who have severe to profound retinitis pigmentosa, experience bare or no light perception in both eyes and have "previous history of useful form vision."


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