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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 Device (OVD), Healon GV PRO
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Drive
suite 200
Irvine, CA 92618
PMA NumberP810031
Supplement NumberS066
Date Received03/09/2020
Decision Date11/25/2020
Product Code LZP 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for changes in labeling to include a new Warning, modifications to the Device Description and Precautions, and the addition of two surgical techniques for removal of the Healon GV® PRO OVD from the eye.
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