|Trade Name||HEALON, HEALON GV AND HEALON5 SODIUM HYLAURONATE OPHTHALMIC VISCOELASTIC DEVICES|
|Classification Name||aid, surgical, viscoelastic|
|Applicant||ADVANCED MEDICAL OPTICS, INC.|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| location change: manufacturer|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the transfer and expansion of the quality control microbiology laboratory used for the healon, healon gv and healon5 sodium hyaluronate ophthalmic viscoelastic devices. The transfer includes test methods, personnel, and equipment from building 16 to building 23 located in uppsala, sweden.