PMA P170043S005
- Device
- iStent inject W Trabecular Micro-Bypass System
- Applicant
- Glaukos Corporation
- Product code
- OGO
- Decision date
- 2020-07-02
- Generic name
- Intraocular pressure lowering implant
- Approval order statement
- Approval for design changes to the stent implant and injector.
Current openFDA PMA Record#
- Device
- iStent inject W Trabecular Micro-Bypass System
- Applicant
- Glaukos Corporation
- PMA number
- P170043
- Supplement
- S005
- Product code
- OGO
- Generic name
- Intraocular pressure lowering implant
- Decision date
- 2020-07-02
- Decision code
- APPR
- Date received
- 2019-11-29
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for design changes to the stent implant and injector.