PMA P170043S007
- Device
- iStent inject Trabecular Micro-Bypass System
- Applicant
- Glaukos Corporation
- PMA number
- P170043
- Supplement
- S007
- Product code
- OGO
- Decision date
- 2020-04-30
- Generic name
- Intraocular pressure lowering implant
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- iStent inject Trabecular Micro-Bypass System
- Applicant
- Glaukos Corporation
- PMA number
- P170043
- Supplement
- S007
- Product code
- OGO
- Generic name
- Intraocular pressure lowering implant
- Decision date
- 2020-04-30
- Decision code
- APPR
- Date received
- 2020-03-03
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.