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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameACRYSOF NATURAL SINGLE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL SB30AL)
Classification Nameintraocular lens
Generic Nameintraocular lenses
Regulation Number886.3600
ApplicantALCON LABORATORIES
PMA NumberP930014
Supplement NumberS009
Date Received12/26/2001
Decision Date06/24/2003
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the acrysof natural single piece intraocular lens (model sb30al). The device is indicated for the replacement of the human lens to achieve visual correction of aphakia in adults when extracapsular cataract extraction or phacoemulsifica-tion are performed. These lenses are intended for placement in the capsular bag.
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