HYDRUS MICROSTENT
FDA premarket approval P170034 · decided 2018-08-10
Approval details
- PMA number
- P170034
- Trade name
- HYDRUS MICROSTENT
- Generic name
- Intraocular pressure lowering implant
- Applicant
- Alcon Research, LLC
- Date received
- 2017-10-30
- Decision date
- 2018-08-10
- Days to decision
- 284 days
- Decision code
- APPR
- Product code
- OGO
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Approval for the Hydrus® Microstent. This device is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate primary open-angle glaucoma (POAG).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| LEGION System (K191650) | Alcon Research, LLC | 2019-11-01 |