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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 NumberS086
Date Received07/07/2003
Decision Date11/18/2003
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 A LINE EXTENSION TO THE LCS COMPLETE FEMORAL COMPONENTS. THAT IS, THE ADDITION OF LCS COMPLETE MODULAR FEMORAL COMPONENTS (SIZES SMALL - LARGE+). THE LCS COMPLETE MODULAR FEMORAL COMPONENTS COMBINE FEATURES OF THE PREVIOUSLY APPROVED LCS COMPLETE PRIMARY AND REVISION FEMORAL COMPONENTS.
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