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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 NameREZOOM MULTIFOCAL ACRYLIC IOL
Classification Namelens, multifocal intraocular
Regulation Number886.3600
ApplicantABBOTT MEDICAL OPTICS INC
PMA NumberP960028
Supplement NumberS031
Date Received11/24/2008
Decision Date12/23/2008
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 
Change in the sampling plan used for dimensional inspection of three-piece soft acrylic intraocular lenses.
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