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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
SECOND SIGHT, LLC.
12744 san fernando rd.
building 3
sylmar, CA 91342
HDE NumberH110002
Supplement NumberS007
Date Received10/07/2014
Decision Date11/06/2014
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 
Use new hardware and software to automate the production and verification of the file directories and file structures for the device¿s three usb drives.
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