PMA P170034S005
- Device
- Hydrus Microsent
- Applicant
- Alcon Research, LLC
- Product code
- OGO
- Decision date
- 2021-06-04
- Generic name
- Intraocular pressure lowering implant
- Approval order statement
- Approval for modified labeling that reflects the findings of the Post-Approval Study (PAS) designated as Continuation of Premarket Cohort PAS.
Current openFDA PMA Record#
- Device
- Hydrus Microsent
- Applicant
- Alcon Research, LLC
- PMA number
- P170034
- Supplement
- S005
- Product code
- OGO
- Generic name
- Intraocular pressure lowering implant
- Decision date
- 2021-06-04
- Decision code
- APPR
- Date received
- 2020-12-07
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for modified labeling that reflects the findings of the Post-Approval Study (PAS) designated as Continuation of Premarket Cohort PAS.