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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.
Classification Nameprosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Generic Nameprosthesis, knee, patellofemorotibial, semi-cons
PMA NumberP830055
Supplement NumberS125
Date Received01/23/2012
Decision Date02/21/2012
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 additional inspection steps to the manufacturing process of the sigma ps femoral components, sigma ps femoral components with lugs and sigma rpf femoral components.