| 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. |
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| Device | Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD) |
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| Generic Name | AID, SURGICAL, VISCOELASTIC |
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| Regulation Number | 886.4275 |
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| Applicant | Johnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618 |
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| PMA Number | P810031 |
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| Supplement Number | S065 |
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| Date Received | 12/03/2018 |
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| Decision Date | 04/29/2019 |
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| Product Code |
LZP |
| Advisory Committee |
Ophthalmic |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
Approval for Healon GV® PRO, a modification of the Healon5 PRO OVD with the sodium hyaluronate concentration changed from 23 mg/mL to 18 mg/mL. The device, as modified, will be marketed under the trade name Sodium Hyaluronate Ophthalmic Viscoelastc Device (OVD), Healon GV® PRO and is indicated for use in anterior segment ophthalmic surgical procedures of the human eye. The Healon GV® PRO OVD is designed to create and maintain a deep anterior chamber which facilitates manipulation inside the eye with reduced trauma to the corneal endothelium and other ocular tissues. The Healon GV® PRO OVD can also be used to efficiently separate and control ocular issues. The Healon GV® PRO OVD is not designed to have any pharmacological effect. |
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