SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, AND HEALON5 PRODUCTS, HEALON ULTIMATE DUAL
FDA premarket approval P810031/S051 · decided 2014-10-08
Approval details
- PMA number
- P810031
- Supplement
- S051
- 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, HEALON ULTIMATE DUAL
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2014-08-29
- Decision date
- 2014-10-08
- Days to decision
- 40 days
- Decision code
- OK30
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- REPLACEMENT OF THE QUALITY CONTROL SODIUM CHLORIDE TEST WITH AN OSMOLALITY TEST IN THE MANUFACTURING OF HEALON® PRODUCTS.
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