PMA P170034S017

Device
Hydrus® Microstent
Applicant
Alcon Research, LLC
PMA number
P170034
Supplement
S017
Product code
OGO
Decision date
2026-04-23
Classification
Ophthalmic
Generic name
Intraocular pressure lowering implant
Approval order statement
an addition of alternate suppliers for non-patient contacting components of the device delivery system

Current openFDA PMA Record#

Device
Hydrus® Microstent
Applicant
Alcon Research, LLC
PMA number
P170034
Supplement
S017
Product code
OGO
Generic name
Intraocular pressure lowering implant
Decision date
2026-04-23
Decision code
OK30
Date received
2026-03-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
an addition of alternate suppliers for non-patient contacting components of the device delivery system