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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 LENSES
Generic NameLens, multifocal intraocular
Regulation Number886.3600
ApplicantAlcon Research, Ltd.
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP040020
Supplement NumberS007
Date Received12/20/2007
Decision Date02/06/2008
Product Code MFK 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ADDITION OF INFORMATION: 1) CLARIFYING THE OPTIKOS MODULATION TRANSFER FUNCTION (MTF) TEST PROCEDURE THAT WAS REVISED; 2) PROVIDING THE SUPPLEMENTARY DATA AND VALIDATION DATA FOR THE SOFTWARE OF THE OPTIKOS MTF BENCH; AND 3) PROVIDING THE SOFTWARE VALIDATION FOR THE ADDITIONAL OPTIKOS MTF SYSTEM TO TEST MULTIFOCAL LENSES.
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