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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 NumberS010
Date Received11/17/2014
Decision Date12/17/2014
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 
Implement changes, to the final device test procedure for the argus ii retinal prosthesis.
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