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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 2s Retinal Prosthesis System
Classification Nameprosthesis, retinal
Generic Nameprosthesis, retinal
Applicant
Cortigent, Inc.
27200 tourney rd., suite 315
valencia, CA 91355
HDE NumberH110002
Supplement NumberS030
Date Received11/21/2019
Decision Date02/26/2021
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 modifications to the external components of the argus ii system.
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