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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 NumberS093
Date Received11/10/2005
Decision Date12/12/2005
Product Code
NJL[ Registered Establishments with NJL ]
Advisory Committee Orthopedic
Supplement Type Special Supplement
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes in quality controls to various components of the lcs total knee system. The changes include modifications to several manufacturing process specifications (mps) for gamma vacuum foil (gvf) packaged products: 1) to add physical separation barriers to the sealing machine to prevent adjacent foil pouches from overlapping during the sealing operation, and 2) to require a second 100% inspection of the seal integrity of each package prior to shipment.
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