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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 Dr.
Irvine, CA 92618
PMA NumberP060022
Supplement NumberS012
Date Received06/21/2011
Decision Date06/18/2012
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE PRIMARY PACKAGING WHICH INCLUDES AN ALTERNATE PLASTIC VIAL AND INTRAOCULAR LENS (IOL) HOLDER.
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