SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, AND HEALON5 PRODUCTS
FDA premarket approval P810031/S044 · decided 2012-04-18
Approval details
- PMA number
- P810031
- Supplement
- S044
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, AND HEALON5 PRODUCTS
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2012-03-30
- Decision date
- 2012-04-18
- Days to decision
- 19 days
- Decision code
- OK30
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- CHANGE TO REPLACE REUSABLE GLASS SAMPLE TUBES WITH DISPOSABLE POLYPROPYLENE SAMPLE TUBES IN THE SODIUM HYALURONATE TEST METHOD.
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