Healon® PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device, Healon Duet® PRO Dual Pack, Healon GV® PRO Sodium Hyaluro
FDA premarket approval P810031/S074 · decided 2023-03-13
Approval details
- PMA number
- P810031
- Supplement
- S074
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Healon® PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device, Healon Duet® PRO Dual Pack, Healon GV® PRO Sodium Hyaluro
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2023-02-14
- Decision date
- 2023-03-13
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Changes to the seal strength test method to align the method with current FDA-recognized industry standard ISO 11607-1.
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