PMA P170034S012
- Device
- Hydrus® Microstent
- Applicant
- Alcon Research, LLC
- PMA number
- P170034
- Supplement
- S012
- Product code
- OGO
- Decision date
- 2024-04-30
- Classification
- Ophthalmic
- Generic name
- Intraocular pressure lowering implant
- Approval order statement
- Changes to incoming inspection requirements for the Hydrus Microstent Implant.
Current openFDA PMA Record#
- Device
- Hydrus® Microstent
- Applicant
- Alcon Research, LLC
- PMA number
- P170034
- Supplement
- S012
- Product code
- OGO
- Generic name
- Intraocular pressure lowering implant
- Decision date
- 2024-04-30
- Decision code
- APPR
- Date received
- 2024-01-18
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to incoming inspection requirements for the Hydrus Microstent Implant.