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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
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 OrderApproval Order
SummarySummary of Safety And Probable Benefit
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S009 S010 
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S020 S021 S022 S023 S024 S026 S028 S029 S030 
S031 S032 S033 
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