PMA P170034S014
- Device
- Hydrus Microstent
- Applicant
- Alcon Research, LLC
- PMA number
- P170034
- Supplement
- S014
- Product code
- OGO
- Decision date
- 2024-12-20
- Classification
- Ophthalmic
- Generic name
- Intraocular pressure lowering implant
- Approval order statement
- a change in the minimum specification limit for in-process burst testing of the sterile barrier system packaging
Current openFDA PMA Record#
- Device
- Hydrus Microstent
- Applicant
- Alcon Research, LLC
- PMA number
- P170034
- Supplement
- S014
- Product code
- OGO
- Generic name
- Intraocular pressure lowering implant
- Decision date
- 2024-12-20
- Decision code
- OK30
- Date received
- 2024-11-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change in the minimum specification limit for in-process burst testing of the sterile barrier system packaging