PMA P170034S003
- Device
- Hydrus Microstent
- Applicant
- Alcon Research, LLC
- PMA number
- P170034
- Supplement
- S003
- Product code
- OGO
- Decision date
- 2019-12-13
- Generic name
- Intraocular pressure lowering implant
- Approval order statement
- Approval for a manufacturing site located at Ivantis, Inc.; 201 Technology; Irvine, California 92618.
Current openFDA PMA Record#
- Device
- Hydrus Microstent
- Applicant
- Alcon Research, LLC
- PMA number
- P170034
- Supplement
- S003
- Product code
- OGO
- Generic name
- Intraocular pressure lowering implant
- Decision date
- 2019-12-13
- Decision code
- APPR
- Date received
- 2019-08-27
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at Ivantis, Inc.; 201 Technology; Irvine, California 92618.