Hydrus Microstent Delivery System
FDA premarket approval P170034/S010 · decided 2023-08-24
Approval details
- PMA number
- P170034
- Supplement
- S010
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Hydrus Microstent Delivery System
- Generic name
- Intraocular pressure lowering implant
- Applicant
- Alcon Research, LLC
- Date received
- 2023-07-26
- Decision date
- 2023-08-24
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- OGO
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Additional supplier, Alcon Precision Devices (APD), of the Delivery System subassembly 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 |