PMA P080030S009
- Device
- GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM
- Applicant
- Glaukos Corporation
- PMA number
- P080030
- Supplement
- S009
- Product code
- OGO
- Decision date
- 2013-06-20
- Classification
- Intraocular Pressure Lowering Implant
- Generic name
- Intraocular pressure lowering implant
- Approval order statement
- ADDITION OF AN ALTERNATE QUALIFIED SUPPLIER OF STEARALKONIUM HEPARIN.
Current openFDA PMA Record#
- Device
- GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM
- Applicant
- Glaukos Corporation
- PMA number
- P080030
- Supplement
- S009
- Product code
- OGO
- Generic name
- Intraocular pressure lowering implant
- Decision date
- 2013-06-20
- Decision code
- OK30
- Date received
- 2013-05-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF AN ALTERNATE QUALIFIED SUPPLIER OF STEARALKONIUM HEPARIN.