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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.
 
DeviceMODEL UPB350NS POSTERIOR CHAMBER INTRAOCULAR LENS
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 NumberS062
Date Received01/16/1991
Decision Date03/28/1994
Withdrawal Date 07/13/2000
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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