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 | S048 |
Date Received | 11/23/2016 |
Decision Date | 01/12/2017 |
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 Introduce an alternative manufacturing material (i.e., liquid penetrant) that is used during the Liquid Penetrant Inspection process of the NexGen Complete Knee Solution, Legacy Knee – Posterior Stabilized (LPS), LPS-Flex Mobile Bearing Knee metal femoral components at the Shannon Ireland facility. |
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