Healon PRO, Healon GV PRO, Healon 5 PRO Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD)
FDA premarket approval P810031/S070 · decided 2022-02-16
Approval details
- PMA number
- P810031
- Supplement
- S070
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Healon PRO, Healon GV PRO, Healon 5 PRO Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD)
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2021-04-01
- Decision date
- 2022-02-16
- Days to decision
- 321 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for an alternative terminal sterilization modality, ethylene oxide, for the Ophthalmic Viscoelastic Devices (OVDs), Healon® PRO, Healon 5® PRO and Healon GV® PRO, in final finished packaging.
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