Glaukos® Corporation iStent inject® W Trabecular Micro-Bypass System
FDA premarket approval P170043/S018 · decided 2023-12-20
Approval details
- PMA number
- P170043
- Supplement
- S018
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Glaukos® Corporation iStent inject® W Trabecular Micro-Bypass System
- Generic name
- Intraocular pressure lowering implant
- Applicant
- Glaukos Corporation
- Date received
- 2023-06-29
- Decision date
- 2023-12-20
- Days to decision
- 174 days
- Decision code
- APPR
- Product code
- OGO
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Clemente, CA
- Statement
- for a change in the sampling plan from 100% inspection to an applicable acceptable quality level (AQL) sampling plan for the singulators manufactured by Resonetics.
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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 |