|
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 |