PMA P170034S010
- Device
- Hydrus Microstent Delivery System
- Applicant
- Alcon Research, LLC
- PMA number
- P170034
- Supplement
- S010
- Product code
- OGO
- Decision date
- 2023-08-24
- Classification
- Ophthalmic
- Generic name
- Intraocular pressure lowering implant
- Approval order statement
- Additional supplier, Alcon Precision Devices (APD), of the Delivery System subassembly of the Hydrus Microstent.
Current openFDA PMA Record#
- Device
- Hydrus Microstent Delivery System
- Applicant
- Alcon Research, LLC
- PMA number
- P170034
- Supplement
- S010
- Product code
- OGO
- Generic name
- Intraocular pressure lowering implant
- Decision date
- 2023-08-24
- Decision code
- OK30
- Date received
- 2023-07-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional supplier, Alcon Precision Devices (APD), of the Delivery System subassembly of the Hydrus Microstent.