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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
Classification Nameprosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Generic Nameprosthesis, knee, patellofemorotibial, semi-cons
ApplicantDEPUY ORTHOPAEDICS, INC.
PMA NumberP830055
Supplement NumberS074
Date Received05/15/2000
Decision Date06/22/2000
Product Code
NJL[ Registered Establishments with NJL ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for minor design modifications to the rotating platform tibial trays and bearings that were originally submitted and approved as part of supplements 57, 61, and 69.
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