PMA P170043S014

Device: iStent Trabecular Micro-Bypass Stent System, iStent inject Trabecular Micro-Bypass System, iStent inject W Trabecular Mi
Applicant: Glaukos Corporation
PMA number: P170043
Supplement: S014
Product code: OGO
Decision date: 2022-08-29
Generic name: Intraocular pressure lowering implant
Approval order statement: Approval for an alternate supplier and modifications to the specifications and incoming receiving testing for the stearalkonium heparin coating raw material.

Current openFDA PMA Record#

Device: iStent Trabecular Micro-Bypass Stent System, iStent inject Trabecular Micro-Bypass System, iStent inject W Trabecular Mi
Applicant: Glaukos Corporation
PMA number: P170043
Supplement: S014
Product code: OGO
Generic name: Intraocular pressure lowering implant
Decision date: 2022-08-29
Decision code: APPR
Date received: 2022-05-31
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for an alternate supplier and modifications to the specifications and incoming receiving testing for the stearalkonium heparin coating raw material.