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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: S023  S020 S021 S022 S004 S012 S011 S018 S019 S015 S016 
S002 S036 S031 S033 S028 S029 S026 S025 S024 S034 S030 S006 
S007 S008 S009 S013 S017 S001 S005 S035 S037 S039 S010 S041 
S040 S045 S056 S058 S055 S062 S050 S046 S047 S048 S049 S044 
S042 S043 S051 S052 S053 S054 S057 S059 S060 S061 
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