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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 LENSES
Generic NameLens, multifocal intraocular
Regulation Number886.3600
ApplicantAlcon Research, Ltd.
6201 South Freeway
Fort Worth, TX 76134-2099
PMA NumberP040020
Supplement NumberS025
Date Received05/03/2010
Decision Date06/02/2010
Product Code MFK 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ELIMINATION OF A QUALITY CONTROL TEST DURING MANUFACTURING OF THE DEVICE.
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