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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.
 
DevicePOLYMETHYLMETH-ACRYLATE INTRAOCULAR LENSES
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBausch & Lomb, Inc.
50 Technology
Irvine, CA 92618
PMA NumberP840039
Supplement NumberS056
Date Received04/03/2008
Decision Date05/02/2008
Product Code HQL 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE IN THE LIMULUS AMEBOCYTE LYSATE (LAL) TESTING METHOD AND A CHANGE IN THE SITE FOR THE LAL FINAL PRODUCT TESTING TO BAUSCH & LOMB, INC.?S CLEARWATER, FLORIDA FACILITY.
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