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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 COMPLETE TOTAL KNEE SYSTEM
Generic NameProsthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
ApplicantDepuy, Inc.
P.O. Box 988
700 Orthopaedic Dr.
Warsaw, IN 46581
PMA NumberP830055
Supplement NumberS115
Date Received11/01/2010
Decision Date03/11/2011
Product Code NJL 
Advisory Committee Orthopedic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR: 1) AUTOMATING ALL MILLING/GRINDING PROCESSES THAT WERE PREVIOUSLY MANUAL; 2) USE OF AN OIL-BASED COOLANT DURING MILLING/ GRINDING; AND 3) INCLUDING A NEW PROCESS ¿ MANUAL IN-PROCESS CLEAN (IPC) TO REMOVE THE OIL-BASED COOLANT AFTER MILLING.
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