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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, HEALON GV, HEALON5 PRODUCTS SODIUM 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 NumberS078
Date Received02/03/2025
Decision Date05/01/2025
Product Code LZP 
Advisory Committee Ophthalmic
Clinical TrialsNCT05575063
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for Healon EndoCoat™ PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD) and Healon Duet PRO™ II Dual Pack Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD)
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