|
Device | iStent inject Trabecular Micro-Bypass System |
Generic Name | Intraocular pressure lowering implant |
Applicant | Glaukos Corporation 229 Avenida Fabricante San Clemente, CA 92672 |
PMA Number | P170043 |
Supplement Number | S003 |
Date Received | 12/14/2018 |
Decision Date | 06/01/2020 |
Product Code |
OGO |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an optional second Collet Holder Assembly in the Model G2-M-IS injector. |