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: AML(R) POROCOAT(R) ACETABULAR CUP PROSTHESIS
• Generic Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Regulation Number: 888.3358
• Applicant: Depuy, Inc.; P.O. Box 988; Warsaw, IN 46581
• PMA Number: P880025
• Supplement Number: S003
• Date Received: 07/08/1991
• Decision Date: 12/04/1991
• Product Code: LPH
• Advisory Committee: Orthopedic
• Supplement Type: Normal 180 Day Track
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No