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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 and AUGMENT Injectable
Generic NameFiller, bone void, synthetic peptide
ApplicantBIOMIMETIC THERAPEUTICS,LLC
389 Nichol Mill Ln
FRANKLIN, TN 37067
PMA NumberP100006
Supplement NumberS012
Date Received09/09/2021
Decision Date11/17/2021
Product Code NOX 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for use of an alternate cold chain shipping unit, the AeroSafe A50 13L shipper, in addition to the current U39 shipper utilized for AUGMENT Bone Graft and AUGMENT Injectable.
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