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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 NameINFUSE BONE GRAFT
Classification Namefiller, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
Generic Namerecombinant human bone morphogenetic protein
ApplicantMEDTRONIC SOFAMOR DANEK, INC.
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.
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