- Device
- Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon® PRO, Healon GV® PRO, Healon5® PRO and Healon® Duet PRO
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P810031
- Supplement
- S073
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2023-09-19
- Decision code
- APPR
- Date received
- 2022-09-01
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change in the particle filter used during manufacturing of the subject ophthalmic viscoelastic devices.