PMA P080030S002

Device
GLAUKOS CORPORATION ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM
Applicant
Glaukos Corporation
PMA number
P080030
Supplement
S002
Product code
OGO
Decision date
2012-11-08
Classification
Intraocular Pressure Lowering Implant
Generic name
Intraocular pressure lowering implant
Approval order statement
MODIFICATIONS TO THE DESIGN OF THE OUTER BLISTER TRAY USED FOR DEVICE PACKAGING.

Current openFDA PMA Record#

Device
GLAUKOS CORPORATION ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM
Applicant
Glaukos Corporation
PMA number
P080030
Supplement
S002
Product code
OGO
Generic name
Intraocular pressure lowering implant
Decision date
2012-11-08
Decision code
APPR
Date received
2012-07-09
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
MODIFICATIONS TO THE DESIGN OF THE OUTER BLISTER TRAY USED FOR DEVICE PACKAGING.