PMA P170043S018

Device: Glaukos® Corporation iStent inject® W Trabecular Micro-Bypass System
Applicant: Glaukos Corporation
PMA number: P170043
Supplement: S018
Product code: OGO
Decision date: 2023-12-20
Classification: Ophthalmic
Generic name: Intraocular pressure lowering implant
Approval order statement: for a change in the sampling plan from 100% inspection to an applicable acceptable quality level (AQL) sampling plan for the singulators manufactured by Resonetics.

Current openFDA PMA Record#

Device: Glaukos® Corporation iStent inject® W Trabecular Micro-Bypass System
Applicant: Glaukos Corporation
PMA number: P170043
Supplement: S018
Product code: OGO
Generic name: Intraocular pressure lowering implant
Decision date: 2023-12-20
Decision code: APPR
Date received: 2023-06-29
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: for a change in the sampling plan from 100% inspection to an applicable acceptable quality level (AQL) sampling plan for the singulators manufactured by Resonetics.