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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
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 NumberS011
Date Received05/22/2007
Decision Date10/01/2007
Product Code
NPZ[ Registered Establishments with NPZ ]
Advisory Committee Dental
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL FOR A SCALE UP OF THE MANUFACTURING OF THE DRUG COMPONENT FOR THE GEM 21? COMBINATION PRODUCT.
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