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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.
 
DevicePLIOLENS UV ABSORBING SILICONE POST. CHAM. IOL/FOLDABLE IOL MODEL 127(920)
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantAdvanced Medical Optics, Inc.
1700 E. St. Andrew Pl.
P.O. Box 25162
Santa Ana, CA 92705
PMA NumberP940007
Supplement NumberS001
Date Received10/30/1995
Decision Date05/20/1996
Withdrawal Date01/22/2008
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR TIER B POSTERIOR CHAMBER INTRAOCULAR LENS MDOEL 127 AS A PARENT LENS AND THE BLUE CORE POLYMETHYLMETHACRYLATE HAPTIC MATERIAL. THE DEVICE, LENS MODEL 127, WILL BE MARKETED UNDER THE TRADE NAME MDOEL 920
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