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 | S001 |
Date Received | 03/25/2013 |
Decision Date | 10/22/2013 |
Product Code | |
Advisory Committee |
Ophthalmic |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for design changes to the implantable and external components of the argus¿ii system. |
|
|