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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 LENS (IOL)
Generic NameLens, intraocular, accommodative
Regulation Number886.3600
ApplicantBausch & Lomb, Inc.
50 Technology Dr.
Irvine, CA 92618
PMA NumberP030002
Supplement NumberS022
Date Received03/08/2010
Decision Date04/30/2010
Product Code NAA 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO MODIFY THE PHYSICIAN¿S LABELING TO INCLUDE THE ADDITION OF 0.25 DIOPTER INCREMENTS FOR THE CRYSTALENS MODEL AT50AO LENSES IN THE +17 TO +27 DIOPTRIC POWER RANGE AND FOR MODEL AT52AO LENSES IN THE +16 TO +16.75 DIOPTRIC POWER RANGE.
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