FDA.reportPublic FDA data

PMA P150037S010

Device
CyPass Ultra System
Applicant
Alcon Research, Ltd.
PMA number
P150037
Supplement
S010
Product code
OGO
Decision date
2018-07-23
Classification
Intraocular Pressure Lowering Implant
Generic name
Intraocular pressure lowering implant
Approval order statement
Addition of the Sinking Spring, PA facility as an alternative manufacturing site for the CyPass Ultra System and implement changes to the inspection test methods and acceptance criteria for the stent delivery system.

Current openFDA PMA Record#

Device
CyPass Ultra System
Applicant
Alcon Research, Ltd.
PMA number
P150037
Supplement
S010
Product code
OGO
Generic name
Intraocular pressure lowering implant
Decision date
2018-07-23
Decision code
OK30
Date received
2018-06-25
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of the Sinking Spring, PA facility as an alternative manufacturing site for the CyPass Ultra System and implement changes to the inspection test methods and acceptance criteria for the stent delivery system.