Sodium Hyaluronate Ophtalmic Viscoelastc Devices (OVD); Healon PRO, Healon5 PRO, and Healon DUet PRO Dual Pack
FDA premarket approval P810031/S063 · decided 2018-01-26
Approval details
- PMA number
- P810031
- Supplement
- S063
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Sodium Hyaluronate Ophtalmic Viscoelastc Devices (OVD); Healon PRO, Healon5 PRO, and Healon DUet PRO Dual Pack
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2017-10-30
- Decision date
- 2018-01-26
- Days to decision
- 88 days
- Decision code
- APPR
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- 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 fro
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