SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES
FDA premarket approval P810031/S030 · decided 2006-09-13
Approval details
- PMA number
- P810031
- Supplement
- S030
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2006-08-14
- Decision date
- 2006-09-13
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- RELOCATION OF A QUALITY CONTROL LABORATORY USED FOR INCOMING INSPECTION OF RAW MATERIALS (EXCEPT SODIUM HYALURONATE) AND PACKAGING COMPONENTS FOR HEALON PRODUCTS TO A DIFFERENT BUILDING AT THE SAME MANUFACTURING SITE IN THE UPPSALA, SWEDEN FACILITY.
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