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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameSENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
Classification Nameintraocular lens
Generic Namemonofocal posterior chamber intraocular lens
Regulation Number886.3600
ApplicantABBOTT MEDICAL OPTICS INC
PMA NumberP980040
Date Received10/01/1998
Decision Date02/03/2000
Product Code
HQL[ Registered Establishments with HQL ]
Docket Number 00M=0445
Notice Date 02/16/2000
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S005 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
S020 S021 S022 S023 S024 S025 S026 S027 S028 
S029 S030 S032 S033 S034 S035 S037 S038 S039 
S040 S041 S042 S045 S047 
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