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Device | SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES |
Generic Name | AID, SURGICAL, VISCOELASTIC |
Regulation Number | 886.4275 |
Applicant | Johnson & Johnson Surgical Vision, Inc. 31 Technology Drive suite 200 Irvine, CA 92618 |
PMA Number | P810031 |
Supplement Number | S030 |
Date Received | 08/14/2006 |
Decision Date | 09/13/2006 |
Product Code |
LZP |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order 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. |