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: P.C.A.(TM) TOTAL KNEE SYSTEM
• Generic Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Regulation Number: 888.3530
• Applicant: Howmedica Corp.; 359 Veterans Blvd.; Rutherford, NJ 07070
• PMA Number: P840049
• Supplement Number: S001
• Date Received: 05/03/1989
• Decision Date: 09/10/1991
• Withdrawal Date: 02/09/1999
• Product Code: HRY
• Advisory Committee: Orthopedic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No