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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
Classification Namebone grafting material, dental, with biologic component
Generic Namebone grafting material, dental, with biologic component
Regulation Number872.3930
Applicant
MEDTRONIC Inc.
1800 pyramid place
memphis, TN 38132
PMA NumberP050053
Date Received12/30/2005
Decision Date03/09/2007
Product Code
NPZ[ Registered Establishments with NPZ ]
Docket Number 07M-0084
Notice Date 03/13/2007
Advisory Committee Dental
Expedited Review Granted? No
Combination Product Yes
Recalls CDRH 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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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 S047 S048 S049 
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