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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameENDURANCE BONE CEMENT
Classification Namebone cement
Generic Namedepuy bone cements
Regulation Number888.3027
ApplicantDEPUY, INC.
PMA NumberP960001
Supplement NumberS001
Date Received02/25/1997
Decision Date11/12/1997
Product Code
LOD[ Registered Establishments with LOD ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for new pmma/mma-styrene co-polymer formulation. The device, as modified, will be marketed under the trade endurace bone cement and is indicated for the fixation of prostheses to living bone in orthopedic musculoskeletal srugical procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other condtions and revision of previous arthroplasty.
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