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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
Generic NameLens, intraocular, accommodative
Regulation Number886.3600
ApplicantBausch & Lomb, Inc.
50 Technology Dr.
Irvine, CA 92618
PMA NumberP030002
Supplement NumberS014
Date Received12/17/2007
Decision Date06/19/2008
Product Code NAA 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
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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