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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.
Classification Nameprosthesis, retinal
Generic Nameprosthesis, retinal
12744 san fernando rd.
building 3
sylmar, CA 91342
HDE NumberH110002
Supplement NumberS017
Date Received05/21/2015
Decision Date07/28/2015
Product Code
NBF[ Registered Establishments with NBF ]
Advisory Committee Ophthalmic
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the new receptacle on the video processing unit (vpu) for connecting the argus ii glasses. The device, as modified, will be marketed under the trade name argus¿ ii retinal prosthesis system and indicated for 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 will be 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.