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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 NumberS070
Date Received02/17/2000
Decision Date03/30/2000
Product Code NJL 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the additional manufacturing facility located at DePuy-Raynham, a Division of DePuy Orthopaedics, Raynham, Massachusetts.
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