| 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. |
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| Trade Name | ARGUS II RETINAL PROSTHESIS SYSTEM |
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| Classification Name | prosthesis, retinal |
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| Generic Name | prosthesis, retinal |
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| Applicant |
| Cortigent, Inc. |
| 27200 tourney rd., suite 315 |
| valencia, CA 91355 |
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| HDE Number | H110002 |
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| Date Received | 05/04/2011 |
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| Decision Date | 02/13/2013 |
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| Product Code | |
| Docket Number | M-0205 |
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| Notice Date | 02/13/2013 |
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| Advisory Committee |
Ophthalmic |
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| Clinical Trials |
NCT00407602
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| Supplement Type | hde original |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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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
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| Post-Approval Study | Show 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 |
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