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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
Applicant
BIOMIMETIC THERAPEUTICS,LLC
389 nichol mill ln
franklin, TN 37067
PMA NumberP100006
Supplement NumberS009
Date Received04/11/2019
Decision Date09/11/2019
Product Code NOX 
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for use of lot UV0023 of the drug substance rhPDGF-BB manufactured by Novartis to be used in the manufacture of the drug product used in AUGMENT Bone Graft and AUGMENT Injectable.
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