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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
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP810031
Supplement NumberS024
Date Received07/10/2002
Decision Date07/25/2002
Product Code LZP 
Advisory Committee Ophthalmic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MODIFICATION OF THE "PRECAUTION" SECTION OF THE PACKAGE INSERT TO INCLUDE THE FOLLOWING: "BEFORE INITIATING PHACOEMULSIFICA-TION, USE IRRIGATION/ ASPIRATION TO CREATE A FLUID-FILLED SPACE ABOVE THE LENS. THIS REDUCES THE RISK OF INITIAL VISCO-OCCULSION OF THE PHACO TIP OR THE IRRIGATION LINE WHICH COULD CAUSE PHACO TIP HEATING."
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