|Trade Name||AOSEPT (R) LENS CUP & AODISC NEUTRALIZER|
|Classification Name||accessories, soft lens products|
|Applicant||CIBA VISION CARE|
|Supplement Type||normal 180 day track|
|Supplement Reason|| location change: manufacturer|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modifications to the currently approved aosept lens cup and aodisc neutralizer to inlcude a cup manufacturing site change, cup material change, cup and disc design change, and corresponding labeling changes. The new primary manufacturing site is tenax corporation, 124 franklin park avenue, youngsville, nc 27596. Secondary manufacturing site is tenax corp, 2450 laura duncan road, apex, nc 27502.