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 | S078 |
Date Received | 05/15/2001 |
Decision Date | 06/13/2001 |
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 APPROVAL FOR THE ADDITION OF REVISION TIBIAL BEARINGS, POROUS-COATED REVISION FEMORAL COMPONENTS, AND FEMORAL AND TIBIAL SLEEVE COMPONENTS. ALSO, APPROVAL FOR MODIFICATIONS TO THE CURRENT TEXTURED REVISION FEMORAL COMPONENTS AND CURRENT REVISION FEMORAL AND TIBIAL AUGMENT COMPONENTS. THE DEVICES, AS MODIFIED, WILL BE MARKETED AS LCS COMPLETE COMPONENTS. |
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