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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 NumberS004
Date Received01/26/2005
Decision Date04/20/2005
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 two changes to the processing of the rhbmp-2 component of the device - the use of a new working cell bank and the use of a longer hold-time (<=120 hours at 2-8 degrees c compared to the current 24 hours) for the matrex cellufine sulfate column.
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