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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.
Classification Namebone grafting material, dental, with biologic component
Regulation Number872.3930
PMA NumberP050053
Supplement NumberS011
Date Received12/23/2008
Decision Date02/20/2009
Product Code
NPZ[ Registered Establishments with NPZ ]
Advisory Committee Dental
Supplement Typereal-time process
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for changes in the exterior cartons used to ship one or more units of infuse bone graft.