PMA P150037S009

Device
CyPass Micro-Stent
Applicant
Alcon Research, Ltd.
PMA number
P150037
Supplement
S009
Product code
OGO
Decision date
2018-05-30
Classification
Intraocular Pressure Lowering Implant
Generic name
Intraocular pressure lowering implant
Approval order statement
Addition of an alternate additional vendor for the stent cleaning step of the CyPass Micro-Stent manufacturing process.

Current openFDA PMA Record#

Device
CyPass Micro-Stent
Applicant
Alcon Research, Ltd.
PMA number
P150037
Supplement
S009
Product code
OGO
Generic name
Intraocular pressure lowering implant
Decision date
2018-05-30
Decision code
OK30
Date received
2018-05-04
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of an alternate additional vendor for the stent cleaning step of the CyPass Micro-Stent manufacturing process.