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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.
 
DeviceACRYSOF INTRAOCULAR LENS (IOL)
Generic Nameintraocular lens
ApplicantALCON LABORATORIES, INC.
6201 SOUTH FREEWAY DR.
FORT WORTH, TX 76134
PMA NumberP930014
Supplement NumberS023
Date Received01/15/2008
Decision Date03/11/2011
Product Codes HQL MFK 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE ACRYSOF INTRAOCULAR LENS (IOL) CASE (#79 AND #80) DRAINAGE FEATURES.
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