FDA.reportPublic FDA data

PMA P150037S011

Device
CyPass System, CyPass Ultra System, CyPass Micro-Stent
Applicant
Alcon Research, Ltd.
PMA number
P150037
Supplement
S011
Product code
OGO
Decision date
2018-08-13
Classification
Intraocular Pressure Lowering Implant
Generic name
Intraocular pressure lowering implant
Approval order statement
Addition of an alternate additional vendor for the laser cutting step in the manufacturing process of the CyPass System Model 241-S and the CyPass Ultra System.

Current openFDA PMA Record#

Device
CyPass System, CyPass Ultra System, CyPass Micro-Stent
Applicant
Alcon Research, Ltd.
PMA number
P150037
Supplement
S011
Product code
OGO
Generic name
Intraocular pressure lowering implant
Decision date
2018-08-13
Decision code
OK30
Date received
2018-07-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of an alternate additional vendor for the laser cutting step in the manufacturing process of the CyPass System Model 241-S and the CyPass Ultra System.