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: ZIMMER DOUGH TYPE & L.V.C.(R) BONE CEMENT
• Generic Name: BONE CEMENT
• Regulation Number: 888.3027
• Applicant: ZIMMER, INC.; P.O. Box 708; Warsaw, IN 46581-0708
• PMA Number: N17755
• Supplement Number: S040
• Date Received: 05/28/1992
• Decision Date: 07/27/1992
• Reclassified Date: 10/14/1999
• Product Code: LOD
• Advisory Committee: Orthopedic
• Supplement Type: Special (Immediate Track)
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No