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. |
|
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 |
|
HDE Number | H110002 |
Supplement Number | S021 |
Date Received | 08/21/2015 |
Decision Date | 09/14/2015 |
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 Update to the implant sterilization procedure to allow exposure to a second ethylene oxide (eo) cycle, vendor qualification for supplying the niobium wall and lidcomponents of the implant and for adopting a revised method to verify hermeticity of the implant. |
|
|