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 | S022 |
Date Received | 11/20/2015 |
Decision Date | 12/10/2015 |
Product Code | |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Change that pertains to the argus ii data acquisition and analysis (adaqa) software that is utilized to perform in process and final device testing of theargus® ii implant and its subassemblies. |
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