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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 St.
Franklin, TN 37064
PMA NumberP040013
Supplement NumberS009
Date Received12/22/2006
Decision Date08/10/2007
Product Code NPZ 
Advisory Committee Dental
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE NEW REFERENCE STANDARD, WHICH IS USED IN THE FOLLOWING ANALYTICAL METHODS: RP-HPLC, SEC, SDS-PAGE, UV, BIOASSAY, ELISA, AND PHH.
Post-Approval StudyShow Report Schedule and Study Progress
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