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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 NameSOFT ACRYLIC INTRAOCULAR LENS
Classification Namelens, multifocal intraocular
Regulation Number886.3600
ApplicantABBOTT MEDICAL OPTICS INC
PMA NumberP960028
Supplement NumberS032
Date Received07/30/2009
Decision Date06/29/2010
Product Code
MFK[ Registered Establishments with MFK ]
Advisory Committee Ophthalmic
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the cycle time for the tumbling process.
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