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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 NameLSC 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 NumberS129
Date Received11/13/2012
Decision Date11/29/2013
Product Code
NJL[ Registered Establishments with NJL ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for manufacturing sites located at steris isomedix, chester, new york, and synergy health switzerland, däniken, switzerland. Both facilities will perform sterilization operations for the lcs total knee system.
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