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: PROSTHESIS, HIP, HEMI-FEMORAL, METAL
• Generic Name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic, cemented
• Applicant: Depuy, Inc.; P.O. Box 988; Warsaw, IN 46581
• PMA Number: P820024
• Supplement Number: S009
• Date Received: 12/12/1986
• Decision Date: 01/21/1987
• Product Code: LPF
• Advisory Committee: Orthopedic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Other
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No