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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 INTRAOCULAR LENSES
Classification Namelens, multifocal intraocular
Generic Name21 cfr 886.3600 intraocular lens(iol)
Regulation Number886.3600
ApplicantALCON RESEARCH, LTD.
PMA NumberP040020
Supplement NumberS008
Date Received01/15/2008
Decision Date03/11/2008
Product Code
MFK[ Registered Establishments with MFK ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for design modifications to the acrysof intraocular lens (iol) case.
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