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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.
 
DeviceAugment® Bone Graft
Generic NameFiller, bone void, synthetic peptide
ApplicantBiomimetic Therapeutics, LLC
389 Nichol Mill Ln.
Franklin, TN 37067
PMA NumberP100006
Supplement NumberS013
Date Received12/15/2021
Decision Date06/13/2022
Product Code NOX 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a modified package insert incorporating updated clinical data based on completion of the postapproval clinical study.
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