- Device
- Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD), Healon GV PRO
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P810031
- Supplement
- S066
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2020-11-25
- Decision code
- APPR
- Date received
- 2020-03-09
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for changes in labeling to include a new Warning, modifications to the Device Description and Precautions, and the addition of two surgical techniques for removal of the Healon GV® PRO OVD from the eye.