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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
Date Received05/04/2011
Decision Date02/13/2013
Product Code
NBF[ Registered Establishments with NBF ]
Docket Number M-0205
Notice Date 02/13/2013
Advisory Committee Ophthalmic
Clinical Trials NCT00407602
Expedited Review Granted? No
Combination ProductNo
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S009 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
S020 S021 S022 
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