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 | LCS® Total Knee System |
Generic Name | Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing |
Applicant | DEPUY, INC. P.O. BOX 988 700 ORTHOPAEDIC DRIVE WARSAW, IN 46581-0988 |
PMA Number | P830055 |
Supplement Number | S311 |
Date Received | 08/04/2023 |
Decision Date | 02/27/2024 |
Product Code |
NJL |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement for partial manufacture of Attune Cemented Cruciate Retaining (CR) and Posterior Stabilized (PS) femoral components at an additional manufacturing facility located at Croom Precision Tooling LTD, SFADCO Enterprise Centre, Croom, Limerick, Ireland. |
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