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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.
Classification Nameprosthesis, retinal
Generic Nameprosthesis, retinal
Cortigent, Inc.
27200 tourney road, suite 315
valencia, CA 91355
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
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the argus™ ii retinal prosthesis system. This device is indicated for use in patients with severe to profound retinitis pigmentosa who meet the following criteria:1) adults, age 25 years or older; 2) bare light or no light perception in both eyes (if the patient has no residual light perception, then evidence of intact inner layer retina function must be confirmed. ); 3) previous history of useful form vision; 4) aphakic or pseudophakic (if the patient is phakic prior to implant, the natural lens willbe removed during the implant procedure. ); and 5) patients who are willing and able to receive the recommended post-implant clinical follow-up, device fitting, and visual rehabilitation. The argus ii implant is intended to be implanted in a single eye, typically the worse-seeing eye.
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 S023 S024 S026 S028 S029 S030 
S031 S032 S033