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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 NumberS007
Date Received08/30/2018
Decision Date06/28/2019
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 Product Yes
Approval Order Statement 
Approval for the following manufacturing sites: Pyramid Laboratories, Inc.3598 Cadillac Avenue Costa Mesa, California 92626 alternate site for the rhPDGF-BB vial tray packagingParter Sterilization Services17115 Kingsview Avenue Carson, California 90746 alternate Ethylene Oxide (EtO) contract sterilizer of finished vial trays
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