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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceINFUSE BONE GRAFT
Generic NameBone grafting material, dental, with biologic component
Regulation Number872.3930
ApplicantMEDTRONIC Inc.
1800 Pyramid Place
Memphis, TN 38132
PMA NumberP050053
Supplement NumberS031
Date Received10/25/2013
Decision Date12/06/2013
Product Code NPZ 
Advisory Committee Dental
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
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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