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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 INTEGRATED KNEE REPLACEMENT SYSTEM
Generic NameProsthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
ApplicantDEPUY, INC.
P.O. BOX 988
700 ORTHOPAEDIC DRIVE
WARSAW, IN 46581-0988
PMA NumberP830055
Supplement NumberS014
Date Received10/16/1989
Decision Date09/26/1990
Product Code NJL 
Docket Number 90M-0335
Notice Date 11/28/1990
Advisory Committee Orthopedic
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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