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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 NameGEM 21S GROWTH FACTOR ENHANCED MATRIX RHPDGF-BB COMPONENT
Classification Namebone grafting material, dental, with biologic component
Generic Namebone grafting material
Regulation Number872.3930
ApplicantBIOMIMETIC THERAPEUTICS, INC.
PMA NumberP040013
Supplement NumberS008
Date Received10/20/2006
Decision Date11/17/2006
Product Code
NPZ[ Registered Establishments with NPZ ]
Advisory Committee Dental
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Add aai pharma-wilmington facility as a qualified facility to conduct a bioassay on the drug component of the device.
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