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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceLCS Total Knee System
Generic NameProsthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
ApplicantDepuy, Inc.
P.O. Box 988
700 Orthopaedic Dr.
Warsaw, IN 46581
PMA NumberP830055
Supplement NumberS255
Date Received08/12/2020
Decision Date09/08/2020
Product Code NJL 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Two changes to the current cleaning agents utilized in final and in-process cleaning: 1) The existing detergent (Galvex 17.30) is replaced by an alternate cleaning detergent (Liquinox); and 2) A new biocide (Acticide SPX) replaced the existing biocide (Dowicil 75) in Citrisurff formulation. These new cleaning agents are used in in-process cleaning and final cleaning steps during the manufacturing process.
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