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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 NumberS015
Date Received11/13/2007
Decision Date08/15/2008
Product Code
MPW[ Registered Establishments with MPW ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track no user fee
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a manufacturing site located at integra neurosciences pr, inc. , anasco, puerto rico, and a sterilizing site at steritech, inc. , salinas, puerto rico.
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