PMA P080030S022

Device: Glaukos Corporation iStent Trabecular Micro-Bypass Stent System
Applicant: Glaukos Corporation
PMA number: P080030
Supplement: S022
Product code: OGO
Decision date: 2018-12-18
Classification: Intraocular Pressure Lowering Implant
Generic name: Intraocular pressure lowering implant
Approval order statement: Changes to the heparin coating procedure and in-process drying method for the iStent Trabecular Micro-Bypass Stent System.

Current openFDA PMA Record#

Device: Glaukos Corporation iStent Trabecular Micro-Bypass Stent System
Applicant: Glaukos Corporation
PMA number: P080030
Supplement: S022
Product code: OGO
Generic name: Intraocular pressure lowering implant
Decision date: 2018-12-18
Decision code: OK30
Date received: 2018-11-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Changes to the heparin coating procedure and in-process drying method for the iStent Trabecular Micro-Bypass Stent System.