HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICES (OVD), (3% SODIUM HYALURONATE)
FDA premarket approval P110007/S007 · decided 2015-12-22
Approval details
- PMA number
- P110007
- Supplement
- S007
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICES (OVD), (3% SODIUM HYALURONATE)
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2015-11-25
- Decision date
- 2015-12-22
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR CHANGES MADE TO THE DIRECTIONS FOR USE (DFU) TO CLARIFY INSTRUCTIONS FOR USE OF THE FINGER GRIP.
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