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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 NumberS016
Date Received11/16/2007
Decision Date03/17/2008
Product Code
MPW[ Registered Establishments with MPW ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for inclusion of a warning related to localized, transient bone resorption in the package insert. The inclusion of this additional warning was prompted by a labeling modification required by the eu as a result of an analysis of reported adverse events.