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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
Date Received12/20/2000
Decision Date04/30/2004
Product Code
MPW[ Registered Establishments with MPW ]
Docket Number 04M-0249
Notice Date 05/26/2004
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the infuse bone graft. The device is indicated for 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.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S008 S009 S010 
S011 S013 S015 S016 S017 S018 S019 S020 S021 
S022 S023 S024 S025 S026 S027 S028 S029 S030 
S031 S032 S033 S034 S035 S036 S037 S038 S039 
S040 
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