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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.
 
DeviceZIMMER NEXGEN LPS-FLEX MOBILE & LPS-MOBILE BEARING KNEE SYSTEMS
Generic NameProsthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
ApplicantZIMMER, INC.
P.O. Box 708
Warsaw, IN 46581-0708
PMA NumberP060037
Supplement NumberS006
Date Received10/10/2008
Decision Date02/13/2009
Product Code NJL 
Advisory Committee Orthopedic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE MANUFACTURING PROCESS FOR THE LPS FEMORAL COMPONENTS, AN ADDITIONAL CLEANING LINE, NEW GRINDING EQUIPMENT, AND AN ADDITIONAL INSPECTION STEP.
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