iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)

FDA premarket approval P170043 · Intraocular pressure lowering implant

PMA numberP170043

Approval

Applicant
Glaukos Corporation
Received
December 21, 2017
Decision date
June 21, 2018 (APPR)
Supplements
18, latest February 24, 2025
Product code
OGO – Intraocular Pressure Lowering Implant

Official FDA PMA record

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.