PMA P170034S015

Device
Hydrus® Microstent
Applicant
Alcon Research, LLC
PMA number
P170034
Supplement
S015
Product code
OGO
Decision date
2025-05-30
Classification
Ophthalmic
Generic name
Intraocular pressure lowering implant
Approval order statement
a change to increase the upper limit of electropolish processing time

Current openFDA PMA Record#

Device
Hydrus® Microstent
Applicant
Alcon Research, LLC
PMA number
P170034
Supplement
S015
Product code
OGO
Generic name
Intraocular pressure lowering implant
Decision date
2025-05-30
Decision code
OK30
Date received
2025-05-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
a change to increase the upper limit of electropolish processing time