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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 EndoCoat Ophthalmic Viscosurgical Device (OVD) (3% Sodium Hyaluronate)
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP110007
Supplement NumberS014
Date Received01/18/2024
Decision Date04/15/2024
Product Code LZP 
Advisory Committee Ophthalmic
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 of an alternative elastomeric plunger stopper used in the primary closure configuration for the Healon EndoCoat Ophthalmic Viscosurgical Device (OVD) (3% Sodium Hyaluronate), and Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon Duet PRO Dual Pack
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