Healon PRO Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon Duet PRO Dual Pack, Healon GV PRO Sodium Hya
FDA premarket approval P810031/S069 · decided 2020-12-16
Approval details
- PMA number
- P810031
- Supplement
- S069
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Healon PRO Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon Duet PRO Dual Pack, Healon GV PRO Sodium Hya
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2020-11-27
- Decision date
- 2020-12-16
- Days to decision
- 19 days
- Decision code
- OK30
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Change to the emulsion used for pretreatment of glass cylinders for Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVDs), including Healon® PRO, Healon GV® PRO, Healon5® PRO and Healon Duet® PRO Dual Pack OVDs.
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