GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L
FDA premarket approval P080030 · decided 2012-06-25
Approval details
- PMA number
- P080030
- Trade name
- GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L
- Generic name
- Intraocular pressure lowering implant
- Applicant
- Glaukos Corporation
- Date received
- 2008-12-19
- Decision date
- 2012-06-25
- Days to decision
- 1284 days
- Decision code
- APPR
- Product code
- OGO
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Laguna Hills, CA
- Statement
- APPROVAL FOR THE GLAUKOS ISTENT® TRABECULAR MICRO-BYPASS STENT (MODELS: GTS-100R, GTS-100L) AND INSERTER (GTS-L00I). THIS DEVICE IS INDICATED FOR USE IN CONJUNCTION WITH CATARACT SURGERY FOR THE REDUCTION OFINTRAOCULAR PRESSURE (IOP) IN ADULT PATIENTS WITH MILD TO MODERATE OPEN-ANGLE GLAUCOMA CURRENTLY TREATED WITH OCULAR HYPOTENSIVE MEDICATION.
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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 |