PMA P080030

Device: iStent® Trabecular Micro-Bypass Stent System
Applicant: Glaukos Corporation
PMA number: P080030
Supplement: S024
Product code: OGO
Decision date: 2026-04-08
Generic name: Intraocular pressure lowering implant
Approval order statement: two new packaging sealers with new sealing parameters used during routine packaging of the iStent® Trabecular Micro-Bypass Stent System.

Current openFDA PMA Record#

Device: iStent® Trabecular Micro-Bypass Stent System
Applicant: Glaukos Corporation
PMA number: P080030
Supplement: S027
Product code: OGO
Generic name: Intraocular pressure lowering implant
Decision date: 2026-04-08
Decision code: APPR
Date received: 2026-01-27
Supplement type: Real-Time Process
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: two new packaging sealers with new sealing parameters used during routine packaging of the iStent® Trabecular Micro-Bypass Stent System.