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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 NameBone grafting material, dental, with biologic component
Regulation Number872.3930
ApplicantMEDTRONIC Inc.
1800 Pyramid Place
Memphis, TN 38132
PMA NumberP050053
Date Received12/30/2005
Decision Date03/09/2007
Product Code NPZ 
Docket Number 07M-0084
Notice Date 03/13/2007
Advisory Committee Dental
Expedited Review Granted? No
Combination ProductYes
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE INFUSE BONE GRAFT. THE DEVICE IS INDICATED AS AN ALTERNATIVE TO AUTOGENOUS BONE GRAFT FOR SINUS AUGMENTATIONS, AND FOR LOCALIZED ALVEOLAR RIDGE AUGMENTATIONS FOR DEFECTS ASSOCIATED WITH EXTRACTION SOCKETS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S004 S005 S006 S007 S008 S009 S010 S011 S012 
S013 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 
S026 S028 S029 S030 S031 S033 S034 S035 S036 S037 S039 S040 
S041 S042 S043 S044 S045 S046 S047 S048 S049 S050 S051 S052 
S053 S054 S055 S056 S057 S058 S059 S060 S061 S062 
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