PMA P170034S013
- Device
- Hydrus Microstent
- Applicant
- Alcon Research, LLC
- PMA number
- P170034
- Supplement
- S013
- Product code
- OGO
- Decision date
- 2025-01-30
- Classification
- Ophthalmic
- Generic name
- Intraocular pressure lowering implant
- Approval order statement
- approval for minor corrections to labeling that reflects the findings of the Post-Approval Study (PAS) designated as “Continuation of Premarket Cohort PAS” or P170034/PAS 001.
Current openFDA PMA Record#
- Device
- Hydrus Microstent
- Applicant
- Alcon Research, LLC
- PMA number
- P170034
- Supplement
- S013
- Product code
- OGO
- Generic name
- Intraocular pressure lowering implant
- Decision date
- 2025-01-30
- Decision code
- APPR
- Date received
- 2024-10-10
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- approval for minor corrections to labeling that reflects the findings of the Post-Approval Study (PAS) designated as “Continuation of Premarket Cohort PAS” or P170034/PAS 001.