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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 USA, INC.
PMA NumberP000054
Supplement NumberS034
Date Received02/17/2012
Decision Date08/01/2013
Product Code
MPW[ Registered Establishments with MPW ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a new neutralizing antibody assay.
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