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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 NameNEW JERSEY LCS(R) TOTAL KNEE SYSTEM
Classification Nameprosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Generic Nameprosthesis, knee, patellofemorotibial, semi-cons
ApplicantDEPUY, INC.
PMA NumberP830055
Supplement NumberS043
Date Received05/23/1995
Decision Date01/02/1996
Product Code
NJL[ Registered Establishments with NJL ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of gas plasma sterilization for polyethylene components.
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