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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 Pl.
P.O. Box 25162
Santa Ana, CA 92705
PMA NumberP860059
Supplement NumberS076
Date Received04/05/1996
Decision Date09/17/1996
Withdrawal Date07/13/2000
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
Predetermined Change Control Plan AuthorizedNo
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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