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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceINFUSE BONE GRAFT
Generic NameFiller, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
ApplicantMedtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
PMA NumberP000054
Date Received12/20/2000
Decision Date04/30/2004
Product Code MPW 
Docket Number 04M-0249
Notice Date 05/26/2004
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductYes
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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 S042 S043 S044 S045 S046 S048 S049 S050 S051 S052 
S053 S054 S055 S056 S057 S058 S059 S060 S061 S062 S063 S064 
S065 S066 S067 S068 S069 S070 S071 
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