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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.
Classification Namefiller, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
Generic Namerecombinant human bone morphogenetic protein
PMA NumberP000054
Supplement NumberS002
Date Received08/02/2004
Decision Date08/09/2004
Product Code
MPW[ Registered Establishments with MPW ]
Advisory Committee Physical Medicine
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for expansion of the upper end of the storage temperature limit for the infuse bone graft component of the device from 25 degrees c to 30 degrees c. The device is indicated for treating acute, open tibial shaft fractures that have been stabilized with im nail fixation after appropriate wound management. Infuse bone graft must be applied within 14 days after the initial fracture. Prospective patients should be skeletally mature.