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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 NumberS006
Date Received07/02/2018
Decision Date09/26/2018
Product Code NOX 
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for an alternate secondary packaging configuration for AUGMENT Injectable and corresponding changes in the AUGMENT Injectable package insert and surgical technique guide reflecting this alternate packaging configuration; re-design of the AUGMENT Injectable kit carton to accommodate a pouch in pouch configuration; and modifications to the payload area and the number of frozen gel packs utilized in the approved shipping unit for both AUGMENT Injectable and AUGMENT Bone Graft.
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