GLAUKOS CORPORATION ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM
FDA premarket approval P080030/S001 · decided 2012-11-15
Approval details
- PMA number
- P080030
- Supplement
- S001
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GLAUKOS CORPORATION ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM
- Generic name
- Intraocular pressure lowering implant
- Applicant
- Glaukos Corporation
- Date received
- 2012-06-29
- Decision date
- 2012-11-15
- Days to decision
- 139 days
- Decision code
- APPR
- Product code
- OGO
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Laguna Hills, CA
- Statement
- APPROVAL OF THE SHELF-LIFE EXTENSION FOR TWO LOTS OF DURAFLO COATING MATERIAL USED IN THE DEVICE.
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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 |