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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 NumberS011
Date Received11/07/2019
Decision Date12/06/2019
Product Code NOX 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for a manufacturing site located at BioMimetic Therapeutics, LLC, 11576 Memphis-Arlington Road, Building C at the Memphis Arlington Campus, Arlington, Tennessee 38002 as an alternate site for product assembly and final kit packaging.
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