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: CMW BONE CEMENT
• Generic Name: BONE CEMENT
• Regulation Number: 888.3027
• Applicant: Depuy, Inc.; P.O. Box 988; Warsaw, IN 46581
• PMA Number: N18466
• Supplement Number: S003
• Date Received: 02/22/1985
• Decision Date: 04/24/1985
• Reclassified Date: 10/14/1999
• Product Code: LOD
• Advisory Committee: Orthopedic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No