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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.
 
DeviceSODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP810031
Supplement NumberS030
Date Received08/14/2006
Decision Date09/13/2006
Product Code LZP 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
RELOCATION OF A QUALITY CONTROL LABORATORY USED FOR INCOMING INSPECTION OF RAW MATERIALS (EXCEPT SODIUM HYALURONATE) AND PACKAGING COMPONENTS FOR HEALON PRODUCTS TO A DIFFERENT BUILDING AT THE SAME MANUFACTURING SITE IN THE UPPSALA, SWEDEN FACILITY.
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