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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 NameAMO REZOOM INTRAOCULAR LENS (IOL) MODEL NXG1
Classification Namelens, multifocal intraocular
Regulation Number886.3600
ApplicantABBOTT MEDICAL OPTICS INC
PMA NumberP960028
Supplement NumberS035
Date Received11/14/2011
Decision Date04/23/2012
Product Code
MFK[ Registered Establishments with MFK ]
Advisory Committee Ophthalmic
Supplement Type135 review track for 30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the test method used to determine bacterial endotoxin levels of intraocular lenses.
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