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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameINFUSE BONE GRAFT
Classification Namebone grafting material, dental, with biologic component
Regulation Number872.3930
ApplicantMEDTRONIC SOFAMOR DANEK USA, INC.
PMA NumberP050053
Supplement NumberS031
Date Received10/25/2013
Decision Date12/06/2013
Product Code
NPZ[ Registered Establishments with NPZ ]
Advisory Committee Dental
Supplement Typereal-time process
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for extension of the rhbmp-2 drug substance expiration date from 60 to 72 months using the approved expiration date modification protocol. The device, as modified, will be marketed under the trade name infuse bone graft and is indicated for the following: an alternative to autogenous bone graft for sinus augmentations, and for localized alveolar ridge augmentations for defects associated with extraction sockets.
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