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 ORTHOPAEDIC BONE CEMENT
• Generic Name: BONE CEMENT
• Regulation Number: 888.3027
• Applicant: DEPUY, INC.; P.O. BOX 988; WARSAW, IN 46581-0988
• PMA Number: N18466
• Supplement Number: S015
• Date Received: 10/19/1993
• Decision Date: 02/15/1994
• Reclassified Date: 10/14/1999
• Product Code: LOD
• Advisory Committee: Orthopedic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: No