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 Mobile and LPS-Mobile Bearing Knee System |
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 | S069 |
Date Received | 09/28/2020 |
Decision Date | 12/21/2020 |
Product Code |
NJL |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Change to the design and materials of the device packaging system for the ultra-high molecular weight polyethylene (UHMWPE) tibial articular surface components of the NexGen LPS-Flex Mobile / LPS-Mobile Bearing Knee System and an associated change to the product shelf life. |
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