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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
Classification Namelens, multifocal intraocular
Generic Namelens, multifocal intraocular
Regulation Number886.3600
Applicant
Alcon Research, Ltd.
6201 south freeway
fort worth, TX 76134-2099
PMA NumberP040020
Supplement NumberS046
Date Received03/20/2013
Decision Date04/17/2013
Product Code
MFK[ Registered Establishments with MFK ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
AN ALTERNATE EO STERILIZATION VENDOR.
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