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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 NumberS014
Date Received07/06/2009
Decision Date08/12/2009
Product Code
NPZ[ Registered Establishments with NPZ ]
Advisory Committee Dental
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL FOR A MANUFACTURING SITE LOCATED IN SHIRLEY, NEW YORK, FOR THE MANUFACTURE OF THE RECOMBINANT HUMAN PLATELET-DERIVED GROWTH FACTOR-BB SYRINGE AND A QUALITY TESTING FACILITY AT ANOTHER LOCATION IN SHIRLEY, NEW YORK, FOR THE TESTING FOR THE RAW MATERIAL, FINISHED PRODUCT RELEASE, AND STABILITY WITH THE EXCEPTION OF THE BIOASSAY FOR THE DRUG COMPONENT OF THE DEVICE.
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