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 | S023 |
Date Received | 12/23/2016 |
Decision Date | 04/25/2017 |
Product Code | |
Advisory Committee |
Ophthalmic |
Supplement Type | normal 75 day track |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for addition of a new supplier to perform the blazing operation of joining the ceramic substrate and niobium wall components of the implant, and for a change to the cleaning process before this braze operation is implemented. |
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