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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) UNICOMPARTMENTAL KNEE
Classification Nameprosthesis, knee, patello/femorotibial, unconstrained, uncemented, porous, coated, polymer/metal/polymer
Generic Nameknee implant - uncemented
ApplicantDEPUY, INC.
PMA NumberP910016
Supplement NumberS006
Date Received05/01/1995
Decision Date12/13/1995
Product Code
MBD[ Registered Establishments with MBD ]
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 ethylene oxide sterilization for polyethylene components.
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