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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 (OVD)-HEALON, HEALON GV, HEALON5, AND HEALON ULTIMATE DUAL PACK
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Drive
suite 200
Irvine, CA 92618
PMA NumberP810031
Supplement NumberS053
Date Received06/03/2015
Decision Date07/01/2015
Product Code LZP 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGING FROM A MANUAL PACKAGING LINE TO AN AUTOMATED INSERTION PROCESS OF THE PRODUCT BLISTER AND/OR CANNULA FOR THE HEALON®, HEALON GV®, HEALON 5®, AND HEALON® ULTIMATE DUAL PACK.
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