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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, Healon Ultimate Dual Pack, Healon
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP810031
Supplement NumberS064
Date Received02/02/2018
Decision Date02/27/2018
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  
Tightening of the endotoxin specification from 0.5 EU/ml to 0.2 EU/ml, an alternate Limulus Amebocyte Lysate (LAL) testing method, and a change to the sampling method for LAL testing for the Healon®, Healon5®, Healon GV®, Healon® Ultimate Dual Pack and Healon Duet® Dual Pack Ophthalmic Viscoelastic Devices (OVDs).
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