GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM
FDA premarket approval P080030/S012 · decided 2014-12-16
Approval details
- PMA number
- P080030
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM
- Generic name
- Intraocular pressure lowering implant
- Applicant
- Glaukos Corporation
- Date received
- 2014-09-30
- Decision date
- 2014-12-16
- Days to decision
- 77 days
- Decision code
- APPR
- Product code
- OGO
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Laguna Hills, CA
- Statement
- APPROVAL FOR THE MODIFICATIONS TO THE MODEL GTS100I INSERTER AND STENT, WHICH COMPRISE THE ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM. THE MODIFICATIONS INCLUDE THEFOLLOWING:1) CHANGES TO THE INSERTER TO INCLUDE:A) A LARGER SLEEVE DIAMETER FOR INCREASED RIGIDITY OF THE SLIDE ASSEMBLY;B) AN INCREASE IN THE INTERNAL SPRING FORCE; C) A CHANGE TO THE GEOMETRY AND EXTENSION OF THE GRASPING TINES ON THE END OF THE SLOTTED TUBE; D) A RE-DESIGN OF THE RELEASE BUTTON ROCKER MECHANISM; AND E) COLOR CHANG
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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 |