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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
Applicant
BIOMIMETIC THERAPEUTICS,LLC
389 nichol mill ln
franklin, TN 37067
PMA NumberP100006
Supplement NumberS003
Date Received09/30/2015
Decision Date10/06/2016
Product Code NOX 
Advisory Committee Orthopedic
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol - osb
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for termination of the New Enrollment Postapproval Study.
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