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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 NameBiologic material, dental
Regulation Number872.3930
ApplicantLynch Biologics, LLC
5526 Joseph St.
Franklin, TN 37064
PMA NumberP040013
Supplement NumberS021
Date Received06/22/2015
Decision Date08/21/2015
Product Code NQA 
Advisory Committee Dental
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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