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Device | iStent inject Trabecular Micro-Bypass System (Model G2-M-IS) |
Generic Name | Intraocular pressure lowering implant |
Applicant | Glaukos Corporation 229 Avenida Fabricante San Clemente, CA 92672 |
PMA Number | P170043 |
Date Received | 12/21/2017 |
Decision Date | 06/21/2018 |
Product Code |
OGO |
Docket Number | 18M-2460 |
Notice Date | 07/09/2018 |
Advisory Committee |
Ophthalmic |
Clinical Trials | NCT01461291
|
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the iStent inject® Trabecular Micro-Bypass System (Model G2-M-IS). This device is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate primary open-angle glaucoma. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S012 S013 S014 S016 S017 S018 |