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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTIER A LENS MODELS UPB360GN AND UP320F
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantADVANCED MEDICAL OPTICS, INC.
1700 E. ST. ANDREW PLACE
P.O. BOX 25162
SANTA ANA, CA 92705-4933
PMA NumberP860059
Supplement NumberS076
Date Received04/05/1996
Decision Date09/17/1996
Withdrawal Date 07/13/2000
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL OF MODELS UPB360GN AND UP320F AS TIER A MODIFICATIONS OF PREVIOUSLY APPROVED PARENT IOLS. MODEL UPB360GN WILL BE MARKETED UNDER THE TRADE NAME TOP NOTCH
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