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 | S056 |
Date Received | 04/23/2018 |
Decision Date | 05/23/2018 |
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 Addition of IMR Laboratories, located at Lansing, New York, USA and Louisville, Kentucky, USA as approved suppliers to complete cleaning residual analysis for validations and process monitoring of the final cleaning process for the NexGen LPS-Flex/LPS-Mobile Bearing Knee System components manufactured in Warsaw, Indiana, USA and Shannon, Ireland facilities. |
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