Basic Information
- Trade Name
- Sodium Hyaluronate Ophtalmic Viscoelastc Devices (OVD); Healon PRO, Healon5 PRO, and Healon DUet PRO Dual Pack
- PMA Number
- P810031
- Supplement Number
- S063
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- January 26, 2018
- Date Received
- October 30, 2017
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee 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.