PMA P080030S011

Device: GLAUKOS ISTENT TRABECULAR MIRCO-BYPASS STENT SYSTEM
Applicant: Glaukos Corporation
PMA number: P080030
Supplement: S011
Product code: OGO
Decision date: 2014-08-29
Classification: Intraocular Pressure Lowering Implant
Generic name: Intraocular pressure lowering implant
Approval order statement: MODIFICATION TO THE ETCHING PROCESS CONSISTING OF THE CHANGES TO THE ETCHING TIME, ACID CONCENTRATION, BATCH SIZE, AND AGITATION METHOD.

Current openFDA PMA Record#

Device: GLAUKOS ISTENT TRABECULAR MIRCO-BYPASS STENT SYSTEM
Applicant: Glaukos Corporation
PMA number: P080030
Supplement: S011
Product code: OGO
Generic name: Intraocular pressure lowering implant
Decision date: 2014-08-29
Decision code: OK30
Date received: 2014-08-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: MODIFICATION TO THE ETCHING PROCESS CONSISTING OF THE CHANGES TO THE ETCHING TIME, ACID CONCENTRATION, BATCH SIZE, AND AGITATION METHOD.