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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.
 
DeviceNEXGEN LPS-FLEX/LPS-MOBILE BEARING KNEE
Generic NameProsthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
ApplicantZIMMER, INC.
P.O. Box 708
Warsaw, IN 46581-0708
PMA NumberP060037
Supplement NumberS013
Date Received05/12/2010
Decision Date10/20/2010
Product Code NJL 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF AN INSPECTION STEP FOR THE FLUTED STEM MOBILE TIBIAL BASEPLATE ENGRAVED LINE FEATURE.
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