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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.
 
DeviceGEM21S 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 NumberS024
Date Received04/17/2020
Decision Date12/04/2020
Product Code NPZ 
Advisory Committee Dental
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Change in supplier for the formulation, filling, and testing (with the exception of the Bioassay) of the rhPDGF-BB syringe component of GEM21S Growth Factor Enhanced Matrix to a manufacturing site located at Pyramid Laboratories, Inc., 3598 Cadillac Ave., Costa Mesa, CA 92626.
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