PMA P080030S017

Device
GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM
Applicant
Glaukos Corporation
PMA number
P080030
Supplement
S017
Product code
OGO
Decision date
2016-05-13
Classification
Intraocular Pressure Lowering Implant
Generic name
Intraocular pressure lowering implant
Approval order statement
Approval for protocol modifications for the PAS2 study.

Current openFDA PMA Record#

Device
GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM
Applicant
Glaukos Corporation
PMA number
P080030
Supplement
S017
Product code
OGO
Generic name
Intraocular pressure lowering implant
Decision date
2016-05-13
Decision code
APPR
Date received
2015-05-26
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol - OSB
Approval order statement
Approval for protocol modifications for the PAS2 study.