PMA P080030S016
- Device
- GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM
- Applicant
- Glaukos Corporation
- PMA number
- P080030
- Supplement
- S016
- Product code
- OGO
- Decision date
- 2015-07-21
- Classification
- Intraocular Pressure Lowering Implant
- Generic name
- Intraocular pressure lowering implant
- Approval order statement
- APPROVAL OF CHANGES TO THE POST-APPROVAL STUDY PROTOCOL.
Current openFDA PMA Record#
- Device
- GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM
- Applicant
- Glaukos Corporation
- PMA number
- P080030
- Supplement
- S016
- Product code
- OGO
- Generic name
- Intraocular pressure lowering implant
- Decision date
- 2015-07-21
- Decision code
- APPR
- Date received
- 2015-05-22
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- APPROVAL OF CHANGES TO THE POST-APPROVAL STUDY PROTOCOL.