- Device
- Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD)
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P810031
- Supplement
- S065
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2019-04-29
- Decision code
- APPR
- Date received
- 2018-12-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for Healon GV® PRO, a modification of the Healon5 PRO OVD with the sodium hyaluronate concentration changed from 23 mg/mL to 18 mg/mL. The device, as modified, will be marketed under the trade name Sodium Hyaluronate Ophthalmic Viscoelastc Device (OVD), Healon GV® PRO and is indicated for use in anterior segment ophthalmic surgical procedures of the human eye. The Healon GV® PRO OVD is designed to create and maintain a deep anterior chamber which facilitates manipulation inside the eye with reduced trauma to the corneal endothelium and other ocular tissues. The Healon GV® PRO OVD can also be used to efficiently separate and control ocular issues. The Healon GV® PRO OVD is not designed to have any pharmacological effect.