Hydrus Microstent Delivery System
PMA P170034
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP170034 | Date10 Aug 2018 | StatusActive |
Official records
- FDA PMA database P170034
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- Hydrus Microstent
- Generic name
- Intraocular pressure lowering implant
- FDA applicant
- Alcon Research, LLC
- PMA number
- FDA product code
- OGO
- Device class
- Class III
- Advisory committee
- Ophthalmic
- FDA decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Hydrus Microstent Delivery System is an Intraocular Pressure Lowering Implant (Device Type: Ophthalmic Device, Nomenclature: OGO). It is a tubular, flexible stent designed to reduce intraocular pressure (IOP) by providing an alternative drainage pathway for aqueous humor in the eye.
This device is supplied sterile and intended for single-use in conjunction with cataract surgery. It is approved for use in adult patients with mild to moderate primary open-angle glaucoma (POAG) and requires surgical implantation via the delivery system. The system is classified as a Class III medical device under FDA regulations and is authorized under PMA number P170034.
Devices cleared under P170034
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Hydrus® Microstent F00022 | F00022 / F00022 | 00867487000134 | — | On the market |
Similar devices
Other devices filed under FDA product code OGO (Intraocular Pressure Lowering Implant).