Hydrus® Microstent
FDA premarket approval P170034/S011 · decided 2024-08-28
Approval details
- PMA number
- P170034
- Supplement
- S011
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Hydrus® Microstent
- Generic name
- Intraocular pressure lowering implant
- Applicant
- Alcon Research, LLC
- Date received
- 2023-08-30
- Decision date
- 2024-08-28
- Days to decision
- 364 days
- Decision code
- APPR
- Product code
- OGO
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- 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
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| LEGION System (K191650) | Alcon Research, LLC | 2019-11-01 |