PMA P080030S014

Device: GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM
Applicant: Glaukos Corporation
PMA number: P080030
Supplement: S014
Product code: OGO
Decision date: 2015-03-24
Classification: Intraocular Pressure Lowering Implant
Generic name: Intraocular pressure lowering implant
Approval order statement: APPROVAL TO UPDATE THE MAGNETIC RESONANCE IMAGING (MRI) INFORMATION IN THE INSTRUCTION FOR USE AND PATIENT ID CARD OF THE ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM.

Current openFDA PMA Record#

Device: GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM
Applicant: Glaukos Corporation
PMA number: P080030
Supplement: S014
Product code: OGO
Generic name: Intraocular pressure lowering implant
Decision date: 2015-03-24
Decision code: APPR
Date received: 2015-02-11
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL TO UPDATE THE MAGNETIC RESONANCE IMAGING (MRI) INFORMATION IN THE INSTRUCTION FOR USE AND PATIENT ID CARD OF THE ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM.