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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceUV ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP880081
Date Received11/07/1988
Decision Date10/31/1989
Product Code HQL 
Docket Number 89M-0475
Notice Date 11/27/1989
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Supplements:  S001 S002 S003 S004 S005 S006 S007 S009 S011 S012 S013 
S014 S017 S018 S019 S020 S022 S023 S024 S026 S027 S029 S030 
S031 S032 S033 S034 S035 S036 S037 S038 S039 S040 S041 S042 
S043 S046 S047 
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