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 | S024 |
Date Received | 03/30/2017 |
Decision Date | 04/28/2017 |
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 An addition of a new supplier to perform the manufacturing operation of connecting the asic (application specific integrated circuit) chip of the implant to the electronics package. |
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