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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.
 
DeviceNEXGEM LPS-FLEX MOBILE AND LPS-MOBILE KNEES
Generic Nameprosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
ApplicantZIMMER, INC.
p.o. box 708
warsaw, IN 46581-0708
PMA NumberP060037
Supplement NumberS020
Date Received09/27/2012
Decision Date03/28/2013
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 CHANGES TO AUTOMATE THE IN-PROCESS DYE PENETRANT TEST.
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