HEALON SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON ENDOCOAT OPHTHALMIC VISCOELASTIC DEVICE (OVD) (3
FDA premarket approval P810031/S046 · decided 2013-01-11
Approval details
- PMA number
- P810031
- Supplement
- S046
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HEALON SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON ENDOCOAT OPHTHALMIC VISCOELASTIC DEVICE (OVD) (3
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2012-10-22
- Decision date
- 2013-01-11
- Days to decision
- 81 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A NEW SECONDARY CARTON PACKAGE CONTAINING ONE HEATON OVD (0.55 ML) AND ONE HEATON® ENDOCOAT OVD (0.85 ML). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HEATON DUET DUAL PACK AND IS INDICATED FOR: HEALON:HEATON® OVD IS INTENDED FOR USE AS A SURGICAL AID IN CATARACT EXTRACTION (INTRA- AND EXTRACAPSULAR), IOL IMPLANTATION, CORNEAL TRANSPLANT, GLAUCOMA FILTRATION AND RETINAL ATTACHMENT SURGERY. HEATON ENDOCOAT:HEATON® ENDOCOAT OVD, MODEL VT585 IS INTENDED FOR USE AS A
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