- Device
- Healon EndoCoat Ophthalmic Viscosurgical Device (OVD) (3% Sodium Hyaluronate)
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P110007
- Supplement
- S014
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2024-04-15
- Decision code
- APPR
- Date received
- 2024-01-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval of an alternative elastomeric plunger stopper used in the primary closure configuration for the Healon EndoCoat Ophthalmic Viscosurgical Device (OVD) (3% Sodium Hyaluronate), and Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon Duet PRO Dual Pack