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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 NumberS077
Date Received09/26/2000
Decision Date11/13/2000
Product Code NJL 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A CHANGE TO THE PACKAGE INSERT REGARDING THE INDICATED USES FOR THE P.F.C. SIGMA RP CURVED TIBIAL BEARINGS. THIS CHANGE IN INDICATION WOULD ALLOW THE P.F.C. SIGMA RP CURVED BEARINGS TO BE USED IN POSTERIOR CRUCIATE RETAINING PROCEDURES WHEN USED WITH THE P.F.C. SIGMA CRUCIATE RETAINING FEMORAL COMPONENT.
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