PMA P170034S009
- Device
- Hydrus® Microstent
- Applicant
- Alcon Research, LLC
- PMA number
- P170034
- Supplement
- S009
- Product code
- OGO
- Decision date
- 2023-04-26
- Classification
- Ophthalmic
- Generic name
- Intraocular pressure lowering implant
- Approval order statement
- Modified in-process cleaning procedures for the Side Interlock Rack Subassembly, Alignment Tube, and Cannula Hub Assembly components of the delivery system.
Current openFDA PMA Record#
- Device
- Hydrus® Microstent
- Applicant
- Alcon Research, LLC
- PMA number
- P170034
- Supplement
- S009
- Product code
- OGO
- Generic name
- Intraocular pressure lowering implant
- Decision date
- 2023-04-26
- Decision code
- OK30
- Date received
- 2023-03-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modified in-process cleaning procedures for the Side Interlock Rack Subassembly, Alignment Tube, and Cannula Hub Assembly components of the delivery system.