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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.
 
DeviceARRAY MULTIFOCAL POSTERIOR CHAMBER INTRAOCULAR LENS
Generic NameLens, multifocal intraocular
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP960028
Supplement NumberS013
Date Received06/28/2005
Decision Date12/21/2005
Product Code MFK 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATION OF THE INDICATION STATEMENT WITH STANDARDIZED LANGUAGE FOR THE MODELS OF THE ARRAY FAMILY OF MULTIFOCAL INTRAOCULAR LENSES (MODELS SA40N, SA40N2, SA40E, AA40E, AA50 AND NXG1). THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ARRAY AND ARE INDICATED FOR: THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WITH AND WITHOUT PRESBYOPIA IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED AND WHO DESIRE NEAR, INTERMEDIATE, AND DISTANCE VISION WITHOUT READING ADD AND INCREASED SPECTACLE, INDEPENDENCE.
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