PMA P170043S004

Device: iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)
Applicant: Glaukos Corporation
PMA number: P170043
Supplement: S004
Product code: OGO
Decision date: 2019-05-30
Classification: Intraocular Pressure Lowering Implant
Generic name: Intraocular pressure lowering implant
Approval order statement: Modification to the endotoxin specification for the injector handpiece for the Glaukos® iStent inject® Trabecular Micro-Bypass System (Model G2-M-IS).

Current openFDA PMA Record#

Device: iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)
Applicant: Glaukos Corporation
PMA number: P170043
Supplement: S004
Product code: OGO
Generic name: Intraocular pressure lowering implant
Decision date: 2019-05-30
Decision code: OK30
Date received: 2019-05-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Modification to the endotoxin specification for the injector handpiece for the Glaukos® iStent inject® Trabecular Micro-Bypass System (Model G2-M-IS).