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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 NumberS006
Date Received08/09/2006
Decision Date09/08/2006
Product Code NPZ 
Advisory Committee Dental
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
SCALING UP THE MANUFACTURING PROCESS TO MOVE FROM 2,000 UNIT BATCHES TO 20,000 UNIT BATCHES.
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