iStent inject Trabecular MicroBypass System
FDA premarket approval P170043/S020 · decided 2025-01-13
Approval details
- PMA number
- P170043
- Supplement
- S020
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- iStent inject Trabecular MicroBypass System
- Generic name
- Intraocular pressure lowering implant
- Applicant
- Glaukos Corporation
- Date received
- 2024-07-18
- Decision date
- 2025-01-13
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- OGO
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Clemente, CA
- Statement
- Request for approval of labeling changes made to the Directions for Use and Package Insert.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| iStent infinite Trabecular Micro-Bypass System, Model iS3 (K220032) | Glaukos Corporation | 2022-08-02 |