PMA P080030S001
- Device
- GLAUKOS CORPORATION ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM
- Applicant
- Glaukos Corporation
- PMA number
- P080030
- Supplement
- S001
- Product code
- OGO
- Decision date
- 2012-11-15
- Classification
- Intraocular Pressure Lowering Implant
- Generic name
- Intraocular pressure lowering implant
- Approval order statement
- APPROVAL OF THE SHELF-LIFE EXTENSION FOR TWO LOTS OF DURAFLO COATING MATERIAL USED IN THE DEVICE.
Current openFDA PMA Record#
- Device
- GLAUKOS CORPORATION ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM
- Applicant
- Glaukos Corporation
- PMA number
- P080030
- Supplement
- S001
- Product code
- OGO
- Generic name
- Intraocular pressure lowering implant
- Decision date
- 2012-11-15
- Decision code
- APPR
- Date received
- 2012-06-29
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL OF THE SHELF-LIFE EXTENSION FOR TWO LOTS OF DURAFLO COATING MATERIAL USED IN THE DEVICE.