- Device
- Healon PRO Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon Duet PRO Dual Pack, Healon GV PRO Sodium Hya
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P810031
- Supplement
- S069
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2020-12-16
- Decision code
- OK30
- Date received
- 2020-11-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the emulsion used for pretreatment of glass cylinders for Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVDs), including Healon® PRO, Healon GV® PRO, Healon5® PRO and Healon Duet® PRO Dual Pack OVDs.