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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.
 
DeviceGEM215 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 NumberS023
Date Received03/24/2020
Decision Date06/17/2020
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  
Approval for change of the supplier from STERIS (formerly Synergy Health) in Swindon, United Kingdom (STERIS Swindon), to the STERIS AST facility located at 9 Apollo Drive, Whippany, New Jersey, United States (STERIS Whippany), for sterilization of the ?-TCP cup component of the GEM21S device.
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