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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.
 
DeviceNEW JERSEY LCS(R) UNICOMPARTMENTAL KNEE
Generic NamePROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
ApplicantDEPUY, INC.
700 ORTHOPAEDIC DR.
WARSAW, IN 46581-0988
PMA NumberP910016
Supplement NumberS005
Date Received04/14/1995
Decision Date12/13/1995
Withdrawal Date 04/18/2012
Product Code MBD 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL OF MINIMUM DOSE GAMMA IRRADIATION VALIDATION FOR POLYETHYLENE COMPONENTS
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