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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 NameARRAY MULTIFOCAL UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRALOCULAR
Classification Namelens, multifocal intraocular
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantALLERGAN, INC.
PMA NumberP960028
Supplement NumberS005
Date Received10/21/1999
Decision Date12/09/1999
Product Code
MFK[ Registered Establishments with MFK ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for expansion of the diopter range from 10-30d to 6-30d.
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