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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.
 
DeviceINTRAOCULAR LENS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantHOYA SURGICAL OPTICS, INC.
14768 PIPELINE AVENUE
CHINO HILLS, CA 91709
PMA NumberP080004
Supplement NumberS002
Date Received02/24/2009
Decision Date07/23/2009
Product Code HQL 
Advisory Committee Ophthalmic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN THE CONTRACTED LIMULUS AMEBOCYTE LYSATE (LAL) TEST LABORATORY.
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