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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
Generic Namebone grafting material, dental, with biologic component
Regulation Number872.3930
ApplicantMEDTRONIC Inc.
PMA NumberP050053
Supplement NumberS019
Date Received09/30/2010
Decision Date08/03/2012
Product Code
NPZ[ Registered Establishments with NPZ ]
Advisory Committee Dental
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for changes to tests performed as part of the ongoing drug product stability program for rhbmp-2 (dibotermin alfa).
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