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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 - PFC SIGMA RPF KNEE SYSTEM
Classification Nameprosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Generic Nameprosthesis, knee, patellofemorotibial, semi-cons
ApplicantDEPUY ORTHOPAEDICS, INC.
PMA NumberP830055
Supplement NumberS092
Date Received10/27/2005
Decision Date11/17/2005
Product Code
NJL[ Registered Establishments with NJL ]
Advisory Committee Orthopedic
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes in quality controls to the femoral components of the above referenced components. These modifications add a requirement for line clearance and a step for color code sticker verification by a second operator to manufacturing process specification (mps) - 1699. The 2nd operator color code sticker verification step is also being added to the travelers for the affected product.
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