PMA P170043S017

Device: iStent inject® W Trabecular Micro-Bypass System
Applicant: Glaukos Corporation
PMA number: P170043
Supplement: S017
Product code: OGO
Decision date: 2023-07-14
Classification: Ophthalmic
Generic name: Intraocular pressure lowering implant
Approval order statement: Addition of iMark Molding (Woodwille, WI) as an alternative supplier for the Hammer Cam component used in the manufacture of the Glaukos iStent inject® W Trabecular Micro-Bypass System (model G2-W).

Current openFDA PMA Record#

Device: iStent inject® W Trabecular Micro-Bypass System
Applicant: Glaukos Corporation
PMA number: P170043
Supplement: S017
Product code: OGO
Generic name: Intraocular pressure lowering implant
Decision date: 2023-07-14
Decision code: OK30
Date received: 2023-06-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of iMark Molding (Woodwille, WI) as an alternative supplier for the Hammer Cam component used in the manufacture of the Glaukos iStent inject® W Trabecular Micro-Bypass System (model G2-W).