iStent inject W Trabecular Micro-Bypass System
FDA premarket approval P170043/S010 · decided 2021-09-10
Approval details
- PMA number
- P170043
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- iStent inject W Trabecular Micro-Bypass System
- Generic name
- Intraocular pressure lowering implant
- Applicant
- Glaukos Corporation
- Date received
- 2021-06-15
- Decision date
- 2021-09-10
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- OGO
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Clemente, CA
- Statement
- Approval for design changes to the Model G2-W injector.
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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 |