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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 St.
Franklin, TN 37064
PMA NumberP040013
Supplement NumberS005
Date Received07/31/2006
Decision Date08/21/2006
Product Code NPZ 
Advisory Committee Dental
Supplement TypeReal-Time Process
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 BMPI STERILITY TEST METHOD TO EXTEND THE EXPIRY DATE TO 36 MONTHS AND IS INDICATED TO TREAT THE FOLLOWING PERIODONTALLY RELATED DEFECTS: 1) INTRABONY PERIODONTAL DEFECTS; 2) FURCATION PERIODONTAL DEFECTS; AND 3) GINGIVAL RECESSION ASSOCIATED WITH PERIODONTAL DEFECTS.
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