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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.
 
DeviceSENSAR & TECNIS ONE-PIECE ACRYLIC POSTERIOR CHAMBER IOLS (MODELS AAB00 & ZCB00)
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP980040
Supplement NumberS015
Date Received05/18/2007
Decision Date10/30/2007
Product Code HQL 
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 FOR TWO NEW MODELS OF SENSAR SOFT ACRYLIC UV LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS) AND THE CLAIMS FOR REDUCED POSTOPERATIVE SPHERICAL ABERRATIONS AND IMPROVED NIGHT-DRIVING SIMULATOR PERFORMANCE. THE NEW MODELS ARE SENSAR ONE-PIECE ACRYLIC POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL AAB00) AND TECNIS ONE-PIECE ACRYLIC POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL ZCB00). THE TWO MODELS DIFFER FROM THE PARENT MODELS AS FOLLOWS: SINGLE PIECE DESIGN, THE ADDITION OF A SURFACE TREATMENT TO THE ACRYLIC MATERIAL, AND SLIGHT REDUCTION IN THE CENTER THICKNESS WITH ZERO ANGULATION.
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