PMA P080030S013
- Device
- ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM
- Applicant
- Glaukos Corporation
- PMA number
- P080030
- Supplement
- S013
- Product code
- OGO
- Decision date
- 2015-08-07
- Classification
- Intraocular Pressure Lowering Implant
- Generic name
- Intraocular pressure lowering implant
- Approval order statement
- APPROVAL TO UPDATE YOUR LABELING TO INCLUDE THE RESULTS OF YOUR POST-APPROVAL STUDY (PAS) FOR THE ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM, EXTENDED FOLLOW-UP OF THE INVESTIGATIONAL DEVICE EXEMPTION (IDE) COHORT STUDY.
Current openFDA PMA Record#
- Device
- ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM
- Applicant
- Glaukos Corporation
- PMA number
- P080030
- Supplement
- S013
- Product code
- OGO
- Generic name
- Intraocular pressure lowering implant
- Decision date
- 2015-08-07
- Decision code
- APPR
- Date received
- 2015-02-09
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL TO UPDATE YOUR LABELING TO INCLUDE THE RESULTS OF YOUR POST-APPROVAL STUDY (PAS) FOR THE ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM, EXTENDED FOLLOW-UP OF THE INVESTIGATIONAL DEVICE EXEMPTION (IDE) COHORT STUDY.