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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.
 
DeviceUV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBausch & Lomb, Inc.
50 Technology
Irvine, CA 92618
PMA NumberP840039
Supplement NumberS031
Date Received08/19/1991
Decision Date02/07/1996
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN ADDITIONAL/ALTERNATEIVE VENDOR FOR POLYMETHYLMETHACRYLATE (PMMA) IWTH ULTRAVIOLET-ABSORBER CYASORB 24 AND NEW FORMULATION OF THE PMMA.
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