Premarket Approval (PMA)

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.

• Device: NEW JERSEY LCS(R) TOTAL KNEE SYSTEM
• Generic Name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
• Applicant: Depuy, Inc.; P.O. Box 988; 700 Orthopaedic Dr.; Warsaw, IN 46581
• PMA Number: P830055
• Supplement Number: S034
• Date Received: 03/14/1994
• Decision Date: 11/30/1994
• Product Code: NJL
• Advisory Committee: Orthopedic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No