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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
12744 san fernando rd.
building 3
sylmar, CA 91342
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.