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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceAUGMENT BONE GRAFT
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
Date Received02/04/2010
Decision Date09/01/2015
Product Code
NOX[ Registered Establishments with NOX ]
Docket Number 15M-3257
Notice Date 10/13/2015
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL FOR AUGMENT® BONE GRAFT. THIS DEVICE 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
Supplements: S001 S002 S003 S004 
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