- Device
- Healon EndoCoat ™ PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD), Healon Duet ™ PRO II Dual Pack Sodium Hya
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P810031
- Supplement
- S080
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2025-10-28
- Decision code
- OK30
- Date received
- 2025-09-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- adoption of the Healon EndoCoat PRO ophthalmic viscosurgical device (OVD) into the existing parametric release procedure from moist heat sterilization for the Healon PRO family of OVD devices