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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 NumberS078
Date Received05/15/2001
Decision Date06/13/2001
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 REVISION TIBIAL BEARINGS, POROUS-COATED REVISION FEMORAL COMPONENTS, AND FEMORAL AND TIBIAL SLEEVE COMPONENTS. ALSO, APPROVAL FOR MODIFICATIONS TO THE CURRENT TEXTURED REVISION FEMORAL COMPONENTS AND CURRENT REVISION FEMORAL AND TIBIAL AUGMENT COMPONENTS. THE DEVICES, AS MODIFIED, WILL BE MARKETED AS LCS COMPLETE COMPONENTS.
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