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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameLCS TOTAL KNEE SYSTEM - ADDITION OF POSTERIOR STABILIZED FEMORAL AND BEARING COMPONENTS & RPII TIBIAL TRAYS & BEARING CO
Classification Nameprosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Generic Nameprosthesis, knee, patellofemorotibial, semi-cons
ApplicantDEPUY, INC.
PMA NumberP830055
Supplement NumberS059
Date Received04/27/1998
Decision Date05/14/1998
Product Code
NJL[ Registered Establishments with NJL ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of multilingual package labeling and a multilingual package insert for the components of the lcs(r) total knee system.
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