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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.
 
DeviceSILICONE INTRAOCULAR LENSES
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBAUSCH & LOMB
50 Technology Drive
Irvine, CA 92618
PMA NumberP910061
Supplement NumberS017
Date Received06/19/2008
Decision Date07/16/2008
Product Code HQL 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
USE OF AN ALTERNATE STERILIZATION CHANGE AT THE STERIS-ISOMEDIX FACILITY.
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