PMA P170043
- Device
- iStent inject® W Trabecular Micro-Bypass System Model iS2
- Applicant
- Glaukos Corporation
- PMA number
- P170043
- Supplement
- S014
- Product code
- OGO
- Decision date
- 2025-02-24
- Generic name
- Intraocular pressure lowering implant
- Approval order statement
- the iStent inject® W Trabecular Micro-Bypass System Model iS2, which implants two Model G2-W stents.
Current openFDA PMA Record#
- Device
- iStent inject® W Trabecular Micro-Bypass System Model iS2
- Applicant
- Glaukos Corporation
- PMA number
- P170043
- Supplement
- S019
- Product code
- OGO
- Generic name
- Intraocular pressure lowering implant
- Decision date
- 2025-02-24
- Decision code
- APPR
- Date received
- 2024-06-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- the iStent inject® W Trabecular Micro-Bypass System Model iS2, which implants two Model G2-W stents.