PMA P170043S009
- Device
- iStent inject W Trabecular Micro-Bypass System
- Applicant
- Glaukos Corporation
- PMA number
- P170043
- Supplement
- S009
- Product code
- OGO
- Decision date
- 2021-08-31
- Generic name
- Intraocular pressure lowering implant
- Approval order statement
- Approval for an alternate manufacturing process and supplier for the singulator holder assembly.
Current openFDA PMA Record#
- Device
- iStent inject W Trabecular Micro-Bypass System
- Applicant
- Glaukos Corporation
- PMA number
- P170043
- Supplement
- S009
- Product code
- OGO
- Generic name
- Intraocular pressure lowering implant
- Decision date
- 2021-08-31
- Decision code
- APPR
- Date received
- 2021-03-25
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an alternate manufacturing process and supplier for the singulator holder assembly.