HEALON ENDOCOAT OPVISCOSURGICAL OPHTHALMIC DEVICE (OVD) (3% SODIUM HYALURONATE)
FDA premarket approval P110007 · decided 2012-07-02
Approval details
- PMA number
- P110007
- Trade name
- HEALON ENDOCOAT OPVISCOSURGICAL OPHTHALMIC DEVICE (OVD) (3% SODIUM HYALURONATE)
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2011-02-22
- Decision date
- 2012-07-02
- Days to decision
- 496 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE HEALON ENDOCOAT OVD. HEALON ENDOCOAT OVD IS AN OPHTHALMIC VISCOELASTIC CONTAINING 3% SODIUM HYALURONATE INDICATED FOR USE AS A SURGICAL AID IN PATIENTS UNDERGOING OPHTHALMIC ANTERIOR SEGMENT SURGICAL PROCEDURES INCLUDING, CATARACT SURGERY WITH AN INTRAOCULAR LENS, CATARACT SURGERY WITHOUT AN INTRAOCULAR LENS, AND SECONDARY INTRAOCULAR LENS IMPLANTATION. HEALON ENDOCOAT OVD MAINTAINS A DEEP CHAMBER DURING ANTERIOR SEGMENT SURGERY, ENHANCES VISUALIZATION DURING THE SURGICAL PROCED
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