PMA P170043S013

Device: iStent inject W Trabecular Micro-Bypass System
Applicant: Glaukos Corporation
Product code: OGO
Decision date: 2022-11-07
Generic name: Intraocular pressure lowering implant
Approval order statement: Approval for a change in the sampling plan from 100% inspection to an applicable acceptable quality level (AQL) sampling plan for the singulators manufactured by Confluent.

Current openFDA PMA Record#

Device: iStent inject W Trabecular Micro-Bypass System
Applicant: Glaukos Corporation
PMA number: P170043
Supplement: S013
Product code: OGO
Generic name: Intraocular pressure lowering implant
Decision date: 2022-11-07
Decision code: APPR
Date received: 2022-05-19
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a change in the sampling plan from 100% inspection to an applicable acceptable quality level (AQL) sampling plan for the singulators manufactured by Confluent.