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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.
Classification Namebone cement
Generic Namebone cement
Regulation Number888.3027
1450 brooks rd.
memphis, TN 38116
PMA NumberP810020
Supplement NumberS004
Date Received07/20/1995
Decision Date07/30/1998
Product Code
LOD[ Registered Establishments with LOD ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes in the bone cement composition. The device, as modified, will be marketed under the trade name Osteopal (E-Flow) and is indicated for use as a bone cement in arthroplastic procedures of the hip, knee, and other joins to fix plastic and metal prosthetic parts to living bone when recondstruction is necessary because of osteoarthritis, nonunion of fractures of the neck of the femur, sickle cell anemai, osteoporosis, secondary severe joint destruction following trauma or toehr conditions (also for fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures.