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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 NumberS070
Date Received11/25/2020
Decision Date12/17/2020
Product Code NJL 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Case for Quality Modified 30-Day Notice for the addition of the validated in-house testing system at the ZOML Shannon microbiology laboratory for the completion of Bacterial Endotoxin, Total Viable Count testing and TOC and conductivity testing of ZOML Shannon water samples. Also, the Firm proposed the addition of microbiological laboratories at the Zimmer GmbH facility in Winterthur, Switzerland site and an external contractor Accugenix for testing of all ZOML Shannon microbial samples requiring species/genus level identification testing.
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