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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
Generic Namebone grafting material, dental, with biologic component
Regulation Number872.3930
1800 pyramid place
memphis, TN 38132
PMA NumberP050053
Supplement NumberS024
Date Received12/19/2011
Decision Date08/01/2013
Product Code
NPZ[ Registered Establishments with NPZ ]
Advisory Committee Dental
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a new neutralizing antibody assay.