PMA P170043S016
- Device
- iStent inject® W Trabecular Micro-Bypass System
- Applicant
- Glaukos Corporation
- PMA number
- P170043
- Supplement
- S016
- Product code
- OGO
- Decision date
- 2023-07-13
- Classification
- Ophthalmic
- Generic name
- Intraocular pressure lowering implant
- Approval order statement
- Adoption of an Acceptable Quality Limit (AQL) sampling plan of 0.65 for the Hammer Cam component manufactured by Micron.
Current openFDA PMA Record#
- Device
- iStent inject® W Trabecular Micro-Bypass System
- Applicant
- Glaukos Corporation
- PMA number
- P170043
- Supplement
- S016
- Product code
- OGO
- Generic name
- Intraocular pressure lowering implant
- Decision date
- 2023-07-13
- Decision code
- OK30
- Date received
- 2023-06-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adoption of an Acceptable Quality Limit (AQL) sampling plan of 0.65 for the Hammer Cam component manufactured by Micron.