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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 Ophtalmic Viscoelastc Devices (OVD); Healon PRO, Healon5 PRO, and Healon DUet PRO Dual Pack
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP810031
Supplement NumberS063
Date Received10/30/2017
Decision Date01/26/2018
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 for the following:1. change in the derivation process of the sodium hyaluronate (HA), which is the rheological active component in the above-mentioned OVDs, from rooster comb derivation to bacterial fermentation;2. change in the supplier of the HA raw material from AMO Uppsala to HTL S.A.S. (Paris, France);3. change in the composition and supplier of the buffer solution, which is used to reconstitute the dried HA into its final intended form;4. change in the buffer solution supplier from Fresenius Kabi Norway AS (Halden, Norway) to Biochrom GMbH (Berlin, Germany);5. change in the silicone emulsion supplier used to siliconize the inner glass cylinder from TriboTec AB (MöInlycke, Sweden) to Bisterfeld Spezialchemie GmbH (Hamburg, Germany); and6. minor changes to the primary packaging components: a. change in the rubber used in the subject devices’ plunger and aluminum cap from chlorobutyl rubber supplied by West Pharmaceutical Services, Inc. (Eschweiler, DE) to bromobutyl rubber supplied by Datwyler Pharma Packaging International (Alken, Belgium); and b. reduction in the dimensions of the inner diameter and head height of the glass cylinder.
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