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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.
 
DeviceGEMS 21S (GROWTH-FACTOR ENHANCED MATRIX)
Generic NameBiologic material, dental
Regulation Number872.3930
ApplicantLynch Biologics, LLC
5526 Joseph St.
Franklin, TN 37064
PMA NumberP040013
Supplement NumberS020
Date Received01/21/2015
Decision Date03/09/2015
Product Code NQA 
Advisory Committee Dental
Supplement TypeSpecial (Immediate Track)
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR FINAL PATIENT LABELING.
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