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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameACRYSOF RESTOR INTRAOCULAR LENSES
Classification Namelens, multifocal intraocular
Generic Name21 cfr 886.3600 intraocular lens(iol)
Regulation Number886.3600
ApplicantALCON LABORATORIES, INC.
PMA NumberP040020
Supplement NumberS056
Date Received02/12/2015
Decision Date03/19/2015
Product Code
MFK[ Registered Establishments with MFK ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Two alternate polypropylene resins, basell pd702 and total m3766.
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