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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 NumberS009
Date Received10/24/2014
Decision Date11/21/2014
Product Code
NBF[ Registered Establishments with NBF ]
Advisory Committee Ophthalmic
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the changes to the argus ii system surgeonmanual.
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