- Device
- Hydrus® Microstent
- Applicant
- Alcon Research, LLC
- PMA number
- P170034
- Supplement
- S011
- Product code
- OGO
- Generic name
- Intraocular pressure lowering implant
- Decision date
- 2024-08-28
- Decision code
- APPR
- Date received
- 2023-08-30
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for a manufacturing site located at Alcon Research, LLC, 714 Columbia Avenue, Sinking Spring, PA 19608, for incoming acceptance activities, component cleaning, assembly, in-process acceptance activities, label printing, packaging, final acceptance activities, bioburden and bacterial endotoxin (BET) testing and a manufacturing site located at Steris AST, 23 Elizabeth Drive, Chester, NY 10918, for gamma irradiation sterilization of the Hydrus Microstent