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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 MODEL AT-45 ACCOMMODATING INTRAOCULAR (IOL)
Generic NameLens, intraocular, accommodative
Regulation Number886.3600
ApplicantBausch & Lomb, Inc.
50 Technology Drive
Irvine, CA 92618
PMA NumberP030002
Supplement NumberS013
Date Received11/05/2007
Decision Date12/12/2007
Product Code NAA 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR INCLUSION OF THE MICROSTAAR MSI-PR AND MSI-TR INJECTORS AND MTC-60C CARTRIDGE IN THE PHYSICIAN LABELING FOR THE CRYSTALENS MODELS AT-50SE AND AT-52SE.
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