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. |
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Device | NexGen LPS-Flex/LPS-Mobile Bearing Knee |
Generic Name | Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing |
Applicant | ZIMMER, INC. P.O. Box 708 Warsaw, IN 46581-0708 |
PMA Number | P060037 |
Supplement Number | S070 |
Date Received | 11/25/2020 |
Decision Date | 12/17/2020 |
Product Code |
NJL |
Advisory Committee |
Orthopedic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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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