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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.
 
DeviceLCS TOTAL KNEE SYSTEM
Generic NameProsthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
ApplicantDEPUY, INC.
P.O. BOX 988
700 ORTHOPAEDIC DRIVE
WARSAW, IN 46581-0988
PMA NumberP830055
Supplement NumberS089
Date Received09/13/2004
Decision Date10/14/2004
Product Code NJL 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF 29 MM MBT REVISION SLEEVES, SIZE MEDIUM LCS COMPLETE FEMORAL AUGMENT BLOCKS, AND THICKER MBT REVISION TIBIAL TRAYS TO THE EXISTING SYSTEM TO PROVIDE SURGEONS WITH A FULL RANGE OF IMPLANT OPTIONS FOR TOTAL KNEE ARTHROPLASTY.
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