GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM
FDA premarket approval P080030/S018 · decided 2016-09-30
Approval details
- PMA number
- P080030
- Supplement
- S018
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM
- Generic name
- Intraocular pressure lowering implant
- Applicant
- Glaukos Corporation
- Date received
- 2015-12-15
- Decision date
- 2016-09-30
- Days to decision
- 290 days
- Decision code
- APPR
- Product code
- OGO
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Laguna Hills, CA
- Statement
- Approvable Pending Inspection
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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 |