PMA P170034S018
- Device
- Hydrus® Microstent
- Applicant
- Alcon Research, LLC
- PMA number
- P170034
- Supplement
- S018
- Product code
- OGO
- Decision date
- 2026-06-04
- Classification
- Ophthalmic
- Generic name
- Intraocular pressure lowering implant
- Approval order statement
- approval for an alternative raw material supplier for Nitinol (NiTi) Tubing
Current openFDA PMA Record#
- Device
- Hydrus® Microstent
- Applicant
- Alcon Research, LLC
- PMA number
- P170034
- Supplement
- S018
- Product code
- OGO
- Generic name
- Intraocular pressure lowering implant
- Decision date
- 2026-06-04
- Decision code
- OK30
- Date received
- 2026-05-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for an alternative raw material supplier for Nitinol (NiTi) Tubing