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 | S147 |
Date Received | 07/31/2014 |
Decision Date | 08/29/2014 |
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 FOR THE COMPUTER AIDED SURGICAL INSTRUMENTS SURGICAL TECHNIQUE, INCLUDING UPDATED ILLUSTRATIONS, CLARIFICATIONS OF SEVERAL STEPS IN THE TECHNIQUE, AND ADDITIONAL INSTRUCTIONS FOR OPTIONAL USE OF A LAMINA SPREADER TECHNIQUE FOR SOFTTISSUE BALANCING. |
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