PMA P080030S023
- Device
- iStent® Trabecular Micro-Bypass Stent System
- Applicant
- Glaukos Corporation
- PMA number
- P080030
- Supplement
- S023
- Product code
- OGO
- Decision date
- 2022-02-18
- Generic name
- Intraocular pressure lowering implant
- Approval order statement
- Change to the sampling plan for Limulus Amebocyte Lysate (LAL) endotoxin testing.
Current openFDA PMA Record#
- Device
- iStent® Trabecular Micro-Bypass Stent System
- Applicant
- Glaukos Corporation
- PMA number
- P080030
- Supplement
- S023
- Product code
- OGO
- Generic name
- Intraocular pressure lowering implant
- Decision date
- 2022-02-18
- Decision code
- OK30
- Date received
- 2022-02-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the sampling plan for Limulus Amebocyte Lysate (LAL) endotoxin testing.