PMA P170043S023

Device: Glaukos® iStent inject® W Trabecular Micro-Bypass System, Glaukos® iStent inject® W Trabecular Micro-Bypass System with
Applicant: Glaukos Corporation
PMA number: P170043
Supplement: S023
Product code: OGO
Decision date: 2026-10-01
Classification: Ophthalmic
Generic name: Intraocular pressure lowering implant
Approval order statement: four changes including Instruction for Use change from printed to electronic format, updated sustainable shipper box, reduced incoming inspection sampling plan for Trocar component, and addition of alternative location for final packaging, labeling and lot release operations on the existing manufacturing campus

Current openFDA PMA Record#

Device: Glaukos® iStent inject® W Trabecular Micro-Bypass System, Glaukos® iStent inject® W Trabecular Micro-Bypass System with
Applicant: Glaukos Corporation
PMA number: P170043
Supplement: S023
Product code: OGO
Generic name: Intraocular pressure lowering implant
Decision date: 2026-10-01
Decision code: OK30
Date received: 2026-09-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: four changes including Instruction for Use change from printed to electronic format, updated sustainable shipper box, reduced incoming inspection sampling plan for Trocar component, and addition of alternative location for final packaging, labeling and lot release operations on the existing manufacturing campus