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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.
 
DeviceAKREOS POSTERIOR CHAMBER INTRAOCULAR LENS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBausch & Lomb, Inc.
50 Technology Drive
Irvine, CA 92618
PMA NumberP060022
Supplement NumberS020
Date Received12/08/2014
Decision Date02/03/2015
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO MODIFY THE LABELING TO INCLUDE THE BAUSCH + LOMB IOLINJECTOR (MODEL VIS100) TO THE VALIDATED INSERTERS LIST ON THE LABELING OF THE AKREOS AO60 INTRAOCULAR LENS (IOL).
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