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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.
 
DeviceTIER A UV-ABSORBING POSTERIOR CHAMBER INTARA. LENS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBausch & Lomb, Inc.
50 Technology
Irvine, CA 92618
PMA NumberP840039
Supplement NumberS030
Date Received08/19/1991
Decision Date02/07/1996
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF D & C GREEN NO.6 DYE TO THE HAPTICS OF THE SINGLE-PIECE POLYMETHYLMETHACRYLATE (PMMA) IOLS UNDER THIS PMA AND MANUFACTURED FROM PMMA SUPPLIED FROM THE ST. LOUIS FACILITY
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