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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 INTEGRATED KNEE REPLACEMENT SYSTEM
Classification Nameprosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Generic Nameprosthesis, knee, patellofemorotibial, semi-cons
ApplicantDEPUY, INC.
PMA NumberP830055
Supplement NumberS014
Date Received10/16/1989
Decision Date09/26/1990
Product Code
NJL[ Registered Establishments with NJL ]
Docket Number 90M-0335
Notice Date 11/28/1990
Advisory Committee Orthopedic
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
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