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. |
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Trade Name | ARGUS II RETINAL PROSTHESIS SYSTEM |
Classification Name | prosthesis, retinal |
Generic Name | prosthesis, retinal |
Applicant |
Cortigent, Inc. |
27200 tourney road, suite 315 |
valencia, CA 91355 |
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HDE Number | H110002 |
Supplement Number | S013 |
Date Received | 02/13/2015 |
Decision Date | 04/29/2015 |
Product Code | |
Advisory Committee |
Ophthalmic |
Supplement Type | normal 75 day track |
Supplement Reason | request for adn |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval in accordance with 613(b) of the food and drug administration safety and innovation act (fdasia), a determination that the humanitarian use device (hud) meets the conditions of either subclause (i) or (ii) under section 520(m)(6)(a)(i) of the federal food, drug, and cosmetic act (fd&c act), as amended by the fdasia, so that the device may be sold for an amount that exceeds the costs of research and development, fabrication, and distribution of the device (i. E. , for profit). The adn for this device has been determined to be 4,000. |
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