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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 NameSENSAR & TECNIS ONE-PIECE ACRYLIC POSTERIOR CHAMBER IOLS (MODELS AAB00 & ZCB00)
Classification Nameintraocular lens
Generic Name intraocular lens
Regulation Number886.3600
ApplicantADVANCED MEDICAL OPTICS, INC.
PMA NumberP980040
Supplement NumberS015
Date Received05/21/2007
Decision Date10/30/2007
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
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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