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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 INTRACULAR LENS (IOL)
Generic NameLens, intraocular, accommodative
Regulation Number886.3600
ApplicantBausch & Lomb, Inc.
50 Technology Dr.
Irvine, CA 92618
PMA NumberP030002
Supplement NumberS019
Date Received05/01/2009
Decision Date06/30/2009
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 HD500 AND HD520 AS FOLLOWS: THE ADDITION OF 0.25 DIOPTER INCREMENTS FOR MODEL HD500 LENSES IN THE +18 TO +22 DIOPTRIC POWER RANGE AND FOR MODEL HD520 LENSES IN THE +16.25 TO +16.75 DIOPTRIC POWER RANGE.
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