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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 MULTIFOCAL POSTERRIOR CHAMBER INTRAOCULAR LENSES
Classification Namelens, multifocal intraocular
Generic Name21 cfr 886.3600 intraocular lens(iol)
Regulation Number886.3600
ApplicantALCON RESEARCH, LTD.
PMA NumberP040020
Supplement NumberS019
Date Received06/30/2009
Decision Date07/23/2009
Product Code
MFK[ Registered Establishments with MFK ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Use of an alternate ethylene oxide gas blend sterilant used during terminal sterilization.
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