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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceDEPUY 3 BONE CEMENT
Generic NameBONE CEMENT
Regulation Number888.3027
ApplicantDepuy, Inc.
700 Orthopaedic Dr.
Warsaw, IN 46581
PMA NumberP960001
Supplement NumberS004
Date Received06/15/1998
Decision Date07/13/1999
Reclassified Date10/14/1999
Product Code LOD 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a new bone cement formulation, in order to change the cement's handling characteristics. The device is indicated for the fixation of prostheses to living bone in Orthopaedic musculoskeletal surgical procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty.
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