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 | S089 |
Date Received | 09/13/2004 |
Decision Date | 10/14/2004 |
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 29 MM MBT REVISION SLEEVES, SIZE MEDIUM LCS COMPLETE FEMORAL AUGMENT BLOCKS, AND THICKER MBT REVISION TIBIAL TRAYS TO THE EXISTING SYSTEM TO PROVIDE SURGEONS WITH A FULL RANGE OF IMPLANT OPTIONS FOR TOTAL KNEE ARTHROPLASTY. |
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