PMA P080030S020

Device: Glaukos iStent Trabecular Micro-Bypass Stent System
Applicant: Glaukos Corporation
PMA number: P080030
Supplement: S020
Product code: OGO
Decision date: 2018-02-06
Classification: Intraocular Pressure Lowering Implant
Generic name: Intraocular pressure lowering implant
Approval order statement: Approval for modifications to the Models GTS100R and GTS100L stents, which are part of the iStent® Trabecular Micro- Bypass Stent System and approval for an alternate supplier for the stents.

Current openFDA PMA Record#

Device: Glaukos iStent Trabecular Micro-Bypass Stent System
Applicant: Glaukos Corporation
PMA number: P080030
Supplement: S020
Product code: OGO
Generic name: Intraocular pressure lowering implant
Decision date: 2018-02-06
Decision code: APPR
Date received: 2017-02-13
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for modifications to the Models GTS100R and GTS100L stents, which are part of the iStent® Trabecular Micro- Bypass Stent System and approval for an alternate supplier for the stents.