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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceGEM 21S GROWTH FACTOR ENHANCED MATRIX RHPDGF-BB COMPONENT
Classification Namebone grafting material, dental, with biologic component
Generic Namebone grafting material, dental, with biologic component
Regulation Number872.3930
Applicant
Luitpold Pharmaceuticals, Inc.
800 adams avenue
suite 100
norristown, PA 19403
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 - manufacturer/sterilizer/packager/supplier
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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