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 | LSC 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 | S129 |
Date Received | 11/13/2012 |
Decision Date | 11/29/2013 |
Product Code |
NJL |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MANUFACTURING SITES LOCATED AT STERIS ISOMEDIX, CHESTER, NEW YORK, AND SYNERGY HEALTH SWITZERLAND, DÄNIKEN, SWITZERLAND. BOTH FACILITIES WILL PERFORM STERILIZATION OPERATIONS FOR THE LCS TOTAL KNEE SYSTEM. |
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