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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHEALON SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON ENDOCOAT OPHTHALMIC VISCOELASTIC DEVICE (OVD) (3
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Drive
suite 200
Irvine, CA 92618
PMA NumberP810031
Supplement NumberS046
Date Received10/22/2012
Decision Date01/11/2013
Product Code LZP 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
RecallsCDRH Recalls
Approval Order 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 SURGICAL AID IN PATIENTS UNDERGOING OPHTHALMIC ANTERIOR SEGMENT PROCEDURES INCLUDING: 1) CATARACT SURGERY WITH AN INTRAOCULAR LENS; 2) CATARACT SURGERY WITHOUT AN INTRAOCULAR LENS; AND 3) SECONDARY INTRAOCULAR LENS IMPLANTATION. HEATON® ENDOCOAT OVD MAINTAINS A DEEP CHAMBER DURING ANTERIOR SEGMENT SURGERY, AIDS IN TISSUE MANIPULATION DURING SURGERY, ENHANCES VISUALIZATION DURING THE SURGICAL PROCEDURE AND PROTECTS THE CORNEAL ENDOTHELIUM AND OTHER OCULAR TISSUE. THE VISCOELASTICITY OF THE SOLUTION MAINTAINS THE NORMAL POSITION OF THE VITREOUS FACE AND PREVENTS FORMATION OF A FLAT CHAMBERDURING SURGERY. IT MAY ALSO BE USED TO COAT INTRAOCULAR LENSES AND INSERTION INSTRUMENTS PRIOR TO INTRAOCULAR LENS IMPLANTATION.
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