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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 NumberS040
Date Received10/25/2013
Decision Date12/06/2013
Product Code
MPW[ Registered Establishments with MPW ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for extension of the rhbmp-2 drug substance expiration date from 60 to 72 months using the approved expiration date modification protocol. The device, as modified, will be marketed under the trade name infuse®bone graft and is indicated for the following: treating acute, open tibial shaft fractures that have been stabilized with im nail fixation after appropriate wound management. Infuse bone graft must be applied within 14 days after the initial fracture. Prospective patients should be skeletally mature.
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