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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 NameLCS TOTAL KNEE SYSTEM: REMAINING ULTRAHIGH MOLECULAR WEIGHT POLYETHYLENE DEVICES
Classification Nameprosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Generic Nameprosthesis, knee, patellofemorotibial, semi-cons
ApplicantDEPUY ORTHOPAEDICS, INC.
PMA NumberP830055
Supplement NumberS072
Date Received03/30/2000
Decision Date04/28/2000
Product Code
NJL[ Registered Establishments with NJL ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to allow the option of manufacturing all approved lcs total knee system ultra high molecular weight polyethylene (uhmwpe) components vacuum-packaged in foil bags and gamma radiation sterilized (the gvf process).
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