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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 ARRAY MULTIFOCAL ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR (IOL)
Classification Namelens, multifocal intraocular
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantALLERGAN, INC.
PMA NumberP960028
Supplement NumberS004
Date Received10/23/1998
Decision Date06/08/1999
Product Code
MFK[ Registered Establishments with MFK ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to expand the diopter range of the array(r) iol from 16-24d to 6-30d in half diopter increments.
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