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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 INJECTABLE
Classification Namefiller, bone void, synthetic peptide
Generic Namefiller, bone void, synthetic peptide
Applicant
BIOMIMETIC THERAPEUTICS,LLC
389 nichol mill ln
franklin, TN 37067
PMA NumberP100006
Supplement NumberS005
Date Received10/31/2016
Decision Date06/12/2018
Product Code
NOX[ Registered Establishments with NOX ]
Docket Number 18M-2335
Notice Date 06/27/2018
Advisory Committee Orthopedic
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for AUGMENT Injectable. This combination product is indicated for use as an alternative to autograft in arthrodesis (i.e., surgical fusion procedures) of the ankle (tibiotalar joint) and/or hindfoot (including subtalar, talonavicular, and calcaneocuboid joints, alone or in combination), due to osteoarthritis, post- traumatic arthritis, rheumatoid arthritis, psoriatic arthritis, avascular necrosis, joint instability, joint deformity, congenital defect, or joint arthropathy in patients with preoperative or intraoperative evidence indicating the need for supplemental graft material.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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