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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 NumberS001
Date Received09/28/2015
Decision Date10/05/2015
Product Code NOX 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR PROPOSED EDITS TO THE PACKAGE INSERT.
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