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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 NumberS024
Date Received03/30/2017
Decision Date04/28/2017
Product Code
NBF[ Registered Establishments with NBF ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
An addition of a new supplier to perform the manufacturing operation of connecting the asic (application specific integrated circuit) chip of the implant to the electronics package.
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