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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 NumberS031
Date Received04/20/2020
Decision Date05/13/2020
Product Code
NBF[ Registered Establishments with NBF ]
Advisory Committee Ophthalmic
Clinical Trials NCT01860092
Supplement Typenormal 75 day track
Supplement Reason postapproval study protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval to terminate the post-approval study "the new enrollment post-approval study of the argus® ii retinal prosthesis".
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