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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device.
 
Trade NameARGUS II RETINAL PROSTHESIS SYSTEM
Classification Nameprosthesis, retinal
Generic Nameprosthesis, retinal
Applicant
Cortigent, Inc.
27200 tourney road, suite 315
valencia, CA 91355
HDE NumberH110002
Supplement NumberS020
Date Received08/21/2015
Decision Date11/04/2015
Product Code
NBF[ Registered Establishments with NBF ]
Advisory Committee Ophthalmic
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for a new supplemental software package ¿swiftprogramming assistant¿ or ¿swiftpa¿ used to expedite and simplify patient programmingprocedures. The device, as modified, will be marketed under the trade name argus¿ ii retinal prosthesis system and indicated for patients with severe to profound retinitis pigmentosa whomeet the following criteria:1) adults, age 25 years or older;2) bare light or no light perception in both eyes. (if the patient has no residual lightperception, then evidence of intact inner layer retina function must be confirmed. );3) previous history of useful form vision. 4) aphakic or pseudophakic. (if the patient is phakic prior to implant, the natural lens will be removed during the implant procedure. );and 5) patients who are willing and able to receive the recommended post-implant clinicalfollow-up, device fitting, and visual rehabilitation.
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