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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.
 
DeviceCRYSTALENS ACCOMMODATING POSTERIOR CHAMBER INTRAOCULAR LENS (AIOL), MODELS AT-45-HD100, HD500, AND HD520
Classification Namelens,intraocular,accommodative
Generic Namelens,intraocular,accommodative
Regulation Number886.3600
Applicant
Bausch & Lomb, Inc.
50 technology drive
irvine, CA 92618
PMA NumberP030002
Supplement NumberS014
Date Received12/17/2007
Decision Date06/19/2008
Product Code
NAA[ Registered Establishments with NAA ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL TO MARKET THE FOLLOWING MODELS IN 0.5 DIOPTER INCREMENTS: MODELS AT-45-HD100 (10 TO 33 DIOPTERS), HD500 (17.0 TO 33.0 DIOPTERS), AND HD520 (10 TO 16.5 DIOPTERS). ADDITIONALLY, APPROVAL TO RECOMMEND USE OF THE STAAR MSI-PR/TR AND MSI-PF/TF INJECTORS WITH MTC-60C CARTRIDGE TO DELIVER THESE LENS MODELS.
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