PMA P080030S026
- Device
- iStent® Trabecular Mjcro-Bypass Stent System, Model GTS100
- Applicant
- Glaukos Corporation
- PMA number
- P080030
- Supplement
- S026
- Product code
- OGO
- Decision date
- 2024-03-28
- Classification
- Ophthalmic
- Generic name
- Intraocular pressure lowering implant
- Approval order statement
- Request for approval of labeling changes made to the Directions for Use and Package Insert.
Current openFDA PMA Record#
- Device
- iStent® Trabecular Mjcro-Bypass Stent System, Model GTS100
- Applicant
- Glaukos Corporation
- PMA number
- P080030
- Supplement
- S026
- Product code
- OGO
- Generic name
- Intraocular pressure lowering implant
- Decision date
- 2024-03-28
- Decision code
- APPR
- Date received
- 2023-10-05
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Request for approval of labeling changes made to the Directions for Use and Package Insert.