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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
Classification Nameprosthesis, knee, patello/femorotibial, unconstrained, uncemented, porous, coated, polymer/metal/polymer
Generic Nameprosthesis, knee, patello/femorotibial, unconstrained, uncemented, porous, coated, polymer/metal/polymer
Applicant
DEPUY, INC.
700 orthopaedic dr.
warsaw, IN 46581-0988
PMA NumberP910016
Supplement NumberS005
Date Received04/14/1995
Decision Date12/13/1995
Product Code
MBD[ Registered Establishments with MBD ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL OF MINIMUM DOSE GAMMA IRRADIATION VALIDATION FOR POLYETHYLENE COMPONENTS
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