Hydrus Microstent
FDA premarket approval P170034/S002 · decided 2019-12-10
Approval details
- PMA number
- P170034
- Supplement
- S002
- 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
- 2019-07-24
- Decision date
- 2019-12-10
- Days to decision
- 139 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 Norman Noble, Inc.; 5507 Avion Park Drive; Highland Heights, Ohio 44143, Contract Manufacturer (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 |