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PMA P810031S063

Device
Sodium Hyaluronate Ophtalmic Viscoelastc Devices (OVD); Healon PRO, Healon5 PRO, and Healon DUet PRO Dual Pack
Applicant
Johnson & Johnson Surgical Vision, Inc.
PMA number
P810031
Supplement
S063
Decision date
2018-01-26
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.

Current openFDA PMA Record#

Device
Sodium Hyaluronate Ophtalmic Viscoelastc Devices (OVD); Healon PRO, Healon5 PRO, and Healon DUet PRO Dual Pack
Applicant
Johnson & Johnson Surgical Vision, Inc.
PMA number
P810031
Supplement
S063
Decision date
2018-01-26
Decision code
APPR
Date received
2017-10-30
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
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.