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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAMO ARRAY MULTIFOCAL ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR (IOL)
Generic NameLens, multifocal intraocular
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP960028
Supplement NumberS004
Date Received10/23/1998
Decision Date06/08/1999
Product Code MFK 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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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