HEALON SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON5 SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVI
FDA premarket approval P810031/S056 · decided 2016-06-14
Approval details
- PMA number
- P810031
- Supplement
- S056
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HEALON SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON5 SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVI
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2015-12-17
- Decision date
- 2016-06-14
- Days to decision
- 180 days
- Decision code
- APPR
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for an alternative secondary blister tray packaging configuration called drop pack for AMOs family of Healon® OVDs that incorporates a transition Tyvek® lid manufactured using DuPonts flash-spinning process.
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