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 | S101 |
Date Received | 01/14/2008 |
Decision Date | 03/13/2008 |
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 FOLLOWING CHANGES TO THE EXISTING LCS COMPLETE RPS FEMORAL COMPONENTS: 1) CHANGES TO INCLUDE MINOR DIMENSIONAL AND TOLERANCE CHANGES; 2) THE DESCRIPTION OF THE DEVICE WILL CHANGE TO LCS COMPLETE RPS FLEXION; AND3) ADDITIONAL LABELING FOR USE IN PATIENTS REQUIRING A HIGHER THAN NORMAL DEGREE OF FLEXION. |
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