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. |
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Device | Augment® Bone Graft |
Generic Name | Filler, bone void, synthetic peptide |
Applicant | BIOMIMETIC THERAPEUTICS,LLC 389 Nichol Mill Ln FRANKLIN, TN 37067 |
PMA Number | P100006 |
Supplement Number | S013 |
Date Received | 12/15/2021 |
Decision Date | 06/13/2022 |
Product Code |
NOX |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for a modified package insert incorporating updated clinical data based on completion of the postapproval clinical study. |
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