Hydrus® Microstent
FDA premarket approval P170034/S012 · decided 2024-04-30
Approval details
- PMA number
- P170034
- Supplement
- S012
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Hydrus® Microstent
- Generic name
- Intraocular pressure lowering implant
- Applicant
- Alcon Research, LLC
- Date received
- 2024-01-18
- Decision date
- 2024-04-30
- Days to decision
- 103 days
- Decision code
- APPR
- Product code
- OGO
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Changes to incoming inspection requirements for the Hydrus Microstent Implant.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| LEGION System (K191650) | Alcon Research, LLC | 2019-11-01 |