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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 RESTOR INTRAOCULAR LENS
Generic NameLens, multifocal intraocular
Regulation Number886.3600
ApplicantAlcon Research, Ltd.
6201 South Freeway
Fort Worth, TX 76134-2099
PMA NumberP040020
Supplement NumberS048
Date Received07/31/2013
Decision Date04/28/2014
Product Code MFK 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THREE ALTERNATE POLYPROPYLENE MATERIALS, BASELL PD702, EXXON ACHIEVE 1605, AND EXXON PP1105E1, FOR INTRAOCULAR LENS (IOL) DEVICE PRIMARY PACKAGING.
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