iStent® Trabecular Mjcro-Bypass Stent System, Model GTS100
FDA premarket approval P080030/S026 · decided 2024-03-28
Approval details
- PMA number
- P080030
- Supplement
- S026
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- iStent® Trabecular Mjcro-Bypass Stent System, Model GTS100
- Generic name
- Intraocular pressure lowering implant
- Applicant
- Glaukos Corporation
- Date received
- 2023-10-05
- Decision date
- 2024-03-28
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- OGO
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Laguna Hills, 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 |