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 | S139 |
Date Received | 09/26/2013 |
Decision Date | 10/29/2013 |
Product Code |
NJL |
Advisory Committee |
Orthopedic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE LABELING (SURGICAL TECHNIQUE) THAT ADD OR STRENGTHEN AN INSTRUCTION THAT IS INTENDED TO ENHANCE THE SAFE USE OF THE DEVICE. ADDITIONAL INSTRUCTIONS ON THE USE OF THE ATTUNE KNEE SYSTEM BALANCED SIZER ARE BEING ADDED TO THE EXISTING SURGICAL TECHNIQUE BASED ON CLINICAL EXPERIENCE GAINED BY SURGEONS. |
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