PMA P810031S078

Device: HEALON, HEALON GV, HEALON5 PRODUCTS SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P810031
Supplement: S078
Product code: LZP
Decision date: 2025-05-01
Classification: Ophthalmic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: approval for Healon EndoCoat™ PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD) and Healon Duet PRO™ II Dual Pack Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD)

Current openFDA PMA Record#

Device: HEALON, HEALON GV, HEALON5 PRODUCTS SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P810031
Supplement: S078
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2025-05-01
Decision code: APPR
Date received: 2025-02-03
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for Healon EndoCoat™ PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD) and Healon Duet PRO™ II Dual Pack Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD)