Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD), Healon GV PRO
FDA premarket approval P810031/S066 · decided 2020-11-25
Approval details
- PMA number
- P810031
- Supplement
- S066
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD), Healon GV PRO
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2020-03-09
- Decision date
- 2020-11-25
- Days to decision
- 261 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for changes in labeling to include a new Warning, modifications to the Device Description and Precautions, and the addition of two surgical techniques for removal of the Healon GV® PRO OVD from the eye.
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