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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 System
Generic NameProsthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
ApplicantZIMMER, INC.
P.O. Box 708
Warsaw, IN 46581-0708
PMA NumberP060037
Supplement NumberS063
Date Received11/21/2019
Decision Date06/18/2020
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 to add Hot Isostatic Pressing (HIP) as an alternate process in the investment casting for NexGen Femoral components (size D, E, and F).
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