iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)
FDA premarket approval P170043 · decided 2018-06-21
Approval details
- PMA number
- P170043
- Trade name
- iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)
- Generic name
- Intraocular pressure lowering implant
- Applicant
- Glaukos Corporation
- Date received
- 2017-12-21
- Decision date
- 2018-06-21
- Days to decision
- 182 days
- Decision code
- APPR
- Product code
- OGO
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Clemente, CA
- Statement
- Approval for the iStent inject® Trabecular Micro-Bypass System (Model G2-M-IS). This device is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate primary open-angle glaucoma.
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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 |