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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 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 NumberS012
Date Received11/23/2007
Decision Date09/03/2008
Product Code NPZ 
Advisory Committee Dental
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol - OSB
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY.
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