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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
Applicant MEDTRONIC 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: manufacturing
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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