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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
Generic NameBone grafting material, dental, with biologic component
Regulation Number872.3930
ApplicantLynch Biologics LLC
5526 Joseph Street
Franklin, TN 37064
PMA NumberP040013
Supplement NumberS014
Date Received07/06/2009
Decision Date08/12/2009
Product Code 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 ProductYes
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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