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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 IQ RESTOR IOLS +3.0 D & +4.0 D ADD POWERS
Generic NameLens, multifocal intraocular
Regulation Number886.3600
ApplicantAlcon Research, Ltd.
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP040020
Supplement NumberS015
Date Received04/02/2009
Decision Date05/28/2009
Product Code MFK 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN EXPANSION OF THE DIOPTRIC RANGE TO INCLUDE 6.0 TO 9.5 DIOPTERS IN ½ DIOPTER INCREMENTS FOR MODELS SN6AD1, MN6AD1 AND SN6AD3.
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